PDA Good Aseptic Manufacturing Conference 2024

Registration Open

Welcome and Introduction

Alte Stuttgarter Reithalle

• Committee Member: Falk Klar, PhD, Parenteral Drug Association

  

  Falk Klar, PhD, Parenteral Drug Association
  

  Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.

Welcome from the Co-Chairs

Alte Stuttgarter Reithalle

• Co-Chair: Simone Biel, PhD, Senior Regulatory Consultant, Merck

  

  Simone Biel, PhD, Senior Regulatory Consultant, Merck
  

  Simone Biel is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing. She provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.

• Co-Chair: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

  

  Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc
  

  Darren has over 25 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems, he is an established SME for these processes, primarily focusing on Fedegari equipment. Darren is an established trainer and has delivered courses on industrial sterilization and autoclave operations across the world over the last 20years, Darren currently leads the Fedegari Technology Center in the US responsible for process consultancy focused on sterilization, decontamination, washing, associated aseptic processes and technical training.

Opening Plenary Part I: Advancing Aseptic Manufacturing for Safe Medicines - Lessons Learned and Path Forward

Alte Stuttgarter Reithalle

• Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

  

  Simone Biel, PhD, Senior Regulatory Consultant, Merck
  

  Simone Biel is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing. She provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.

• 09:15 – 09:45

  Keynote: Empowering Patients Through Good Aseptic Manufacturing: A Vital Journey Towards Safer Medical Products

  • Presenter: Hussain Jafri, PhD, Executive Director , World Patients Alliance

    

    Hussain Jafri, PhD, Executive Director , World Patients Alliance
    

    Hussain Jafri, PhD is the Executive Director of World Patients Alliance. He is also the Secretary General of Alzheimer’s Pakistan, the national association of Alzheimer’s disease and related dementias that Hussain founded in 1999 as a result of his experiences as a care giver for his grandfather with Alzheimer’s Disease. He has been very active in the field of patient safety and has remined the Vice Chair of Advisory Group of WHO’s Patients for Patients Safety Program (PFPS). Hussain has also founded Pakistan Patient Safety Initiative and has been working towards several patient safety initiatives. The Government of the Punjab has also nominated him the Provincial Focal Person on Patients Safety & Quality and given the responsibility of developing patients safety and quality services in the health sector of the Punjab province. He has remarkable experience of working as a volunteer in the social sector and has had an opportunity of working with government, national and international non-profit organizations. Hussain is also a member of the Person and Family Centred Advisory Council (PFCAC) of International Society for Quality in Health Care (ISQua). Moreover, he is also a taskforce member of Global Alliance of Partners for Pain Advocacy (GAPPA). He is an experienced speaker and a resource person and has been presenting nationally and internationally on different issues like patient safety, patients centred healthcare, care giving, advocacy, partnership in health, organizational development, etc. Hussain is a PhD from University of Leeds, UK on prevention of genetic disorders. He is currently working as the Director General of Punjab Thalassaemia & Other Genetic Disorders Prevention & Research Institute and has published several publications in international indexed journals.

• 09:45 – 10:15

  Implementation of EU GMP Annex 1 – Inspection Experiences and Expectations

  • Regulatory Presenter: Christina Meissner, AGES - Austrian Agency for Health and Food Safety

    

    Christina Meissner, AGES - Austrian Agency for Health and Food Safety
    

    Studies of Chemistry and Biology at the University of Vienna, Austria and the Humboldt University Berlin, Germany. PhD Thesis at the Institute of Medical Virology of the Charité University Hospital Berlin Austrian Agency for Health and Food Safety since 2012- GMP Inspector since 2013 Member of the Drafting Group for the Annex VI EU GMP- Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Member of the Drafting Group for PIC/S Working Group on Annex 2 Since Mai 2020 Chair of PIC/S Working Group on Annex 2

• 10:15 – 10:45

  Fit for Future: Sterile Manufacture? A Personal View on Revised EU GMP Annex 1

  • Regulatory Presenter: Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany

    

    Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany
    

    Mr. Daniel Müller studied Pharmacy at the University of Wuerzburg, Germany, followed by a doctorate. He started working in the pharmaceutical industry in 1998. Last he served as a qualified person for sterile products (large volume parenteral). In 2001 he joined a German GMP Inspectorate at Tuebingen, Baden-Wuerttemberg. Since that time he has been working as a GMDP-Inspector with a focus on biotechnological active pharmaceutical ingredients and sterile drug products. Currently, he is head of the GMP Inspectorate at Tuebingen. Additionally, Mr. Müller is a member of the German Expert Group “Quality Assurance”. He has got further qualifications as ‘Fachapotheker für Pharmazeutische Analytik’ (pharmaceutical analytics) and ‚Fachapotheker für Öffentliches Gesundheitswesen’ (public health management).

Networking Coffee Break, Poster Session & Exhibition

Opening Plenary Part II: Advancing Aseptic Manufacturing for Safe Medicines - Lessons Learned and Path Forward

Alte Stuttgarter Reithalle

• Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

  

  Simone Biel, PhD, Senior Regulatory Consultant, Merck
  

  Simone Biel is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing. She provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.

• 11:15 – 11:35

  The Evolution of the CCS from Concept/Conversion to Continuous Improvement

  • Presenter: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• 11:35 – 11:55

  Annex 1 Implementation: A Case Study of the Sterile Production at F. Hoffmann-La Roche Ltd. Kaiseraugst

  • Presenter: Tarik Cheema, PhD, End to End Contamination Control Manager, F. Hoffmann-La Roche AG

    

    Tarik Cheema, PhD, End to End Contamination Control Manager, F. Hoffmann-La Roche AG
    

• 11:55 – 12:00

  Interactive Questionnaire Session
• 12:00 – 12:45

  Plenary Discussion

  • Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

    

    Simone Biel, PhD, Senior Regulatory Consultant, Merck
    

    Simone Biel is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing. She provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.

  • Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

    

    Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc
    

    Darren has over 25 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems, he is an established SME for these processes, primarily focusing on Fedegari equipment. Darren is an established trainer and has delivered courses on industrial sterilization and autoclave operations across the world over the last 20years, Darren currently leads the Fedegari Technology Center in the US responsible for process consultancy focused on sterilization, decontamination, washing, associated aseptic processes and technical training.

  • Panelist: Hussain Jafri, PhD, Executive Director , World Patients Alliance

    

    Hussain Jafri, PhD, Executive Director , World Patients Alliance
    

    Hussain Jafri, PhD is the Executive Director of World Patients Alliance. He is also the Secretary General of Alzheimer’s Pakistan, the national association of Alzheimer’s disease and related dementias that Hussain founded in 1999 as a result of his experiences as a care giver for his grandfather with Alzheimer’s Disease. He has been very active in the field of patient safety and has remined the Vice Chair of Advisory Group of WHO’s Patients for Patients Safety Program (PFPS). Hussain has also founded Pakistan Patient Safety Initiative and has been working towards several patient safety initiatives. The Government of the Punjab has also nominated him the Provincial Focal Person on Patients Safety & Quality and given the responsibility of developing patients safety and quality services in the health sector of the Punjab province. He has remarkable experience of working as a volunteer in the social sector and has had an opportunity of working with government, national and international non-profit organizations. Hussain is also a member of the Person and Family Centred Advisory Council (PFCAC) of International Society for Quality in Health Care (ISQua). Moreover, he is also a taskforce member of Global Alliance of Partners for Pain Advocacy (GAPPA). He is an experienced speaker and a resource person and has been presenting nationally and internationally on different issues like patient safety, patients centred healthcare, care giving, advocacy, partnership in health, organizational development, etc. Hussain is a PhD from University of Leeds, UK on prevention of genetic disorders. He is currently working as the Director General of Punjab Thalassaemia & Other Genetic Disorders Prevention & Research Institute and has published several publications in international indexed journals.

  • Panelist: Tarik Cheema, PhD, End to End Contamination Control Manager, F. Hoffmann-La Roche AG

    

    Tarik Cheema, PhD, End to End Contamination Control Manager, F. Hoffmann-La Roche AG
    

  • Panelist: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

  • Panelist: Christina Meissner, AGES - Austrian Agency for Health and Food Safety

    

    Christina Meissner, AGES - Austrian Agency for Health and Food Safety}
    

    Studies of Chemistry and Biology at the University of Vienna, Austria and the Humboldt University Berlin, Germany. PhD Thesis at the Institute of Medical Virology of the Charité University Hospital Berlin Austrian Agency for Health and Food Safety since 2012- GMP Inspector since 2013 Member of the Drafting Group for the Annex VI EU GMP- Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Member of the Drafting Group for PIC/S Working Group on Annex 2 Since Mai 2020 Chair of PIC/S Working Group on Annex 2

  • Panelist: Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany

    

    Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany
    

    Mr. Daniel Müller studied Pharmacy at the University of Wuerzburg, Germany, followed by a doctorate. He started working in the pharmaceutical industry in 1998. Last he served as a qualified person for sterile products (large volume parenteral). In 2001 he joined a German GMP Inspectorate at Tuebingen, Baden-Wuerttemberg. Since that time he has been working as a GMDP-Inspector with a focus on biotechnological active pharmaceutical ingredients and sterile drug products. Currently, he is head of the GMP Inspectorate at Tuebingen. Additionally, Mr. Müller is a member of the German Expert Group “Quality Assurance”. He has got further qualifications as ‘Fachapotheker für Pharmazeutische Analytik’ (pharmaceutical analytics) and ‚Fachapotheker für Öffentliches Gesundheitswesen’ (public health management).

Networking Lunch Break & Exhibition

Saal MARITIM & Lobby Empore

Guided Poster Walk

Lobby Empore

• 13:30 – 14:00

  Biodecontamination of Raw Materials in Packaging Production Process

  • Poster Presenter: Andrea Weiss

    

    Andrea Weiss
    

• 13:30 – 14:00

  CFD - Computational Fluid Dynamics for Airflow Visualization Studies

  • Poster Presenter: Christian Scarpato, Process Engineering Manager, Merck

    

    Christian Scarpato, Process Engineering Manager, Merck
    

    He is a sterile engineering expert with almost 13 years of experience in pharma companies (sterile and non-sterile manufacturing site). He worked on greenfield projects into the design, installation, and start-up phases in Baxter, GSK and Merck and into day-by-day technical support and on improvment. Recently He worked on three new sterile production lines (vials, cartridges, and syringes) with cutting-edge technology (isolator technology) and advanced automation (SCADA and MES driven manufacturing processes) in Merck Bari site. He currently leads the process engineering team in Merck Bari. He graduated with honours in Chemical Engineering from Federico II University of Naples.

• 13:30 – 14:00

  eBeam Technology – Transfer Technology for Pre-Sterilized RTU Components

  • Poster Presenter: Manfred Holzer, Sales Manager IRE & Product Manager Ebeam Technology, SKAN AG

    

    Manfred Holzer, Sales Manager IRE & Product Manager Ebeam Technology, SKAN AG
    

    Manfred Holzer studied Mechanical Engineering and has been engaged as a sales manager for isolators in the pharmaceutical industry since 1995. Joining SKAN AG in 2000 he worked in various positions, e.g. as international sales & project manager, and USA business coordinator. Since 2016 dedicated Sales Manager for Ireland, he also covered 2008 the strategic product management sPM for pharma beam applications at SKAN.

• 13:30 – 14:00

  Environmental Monitoring in LIMS

  • Poster Presenter: Julia Wiesner, PhD, Senior Director, Head of QC & QA Systems, Merz Pharma GmbH & Co. KGaA

    

    Julia Wiesner, PhD, Senior Director, Head of QC & QA Systems, Merz Pharma GmbH & Co. KGaA
    

    I studied Chemistry (Diploma degree) at the University of Marburg (2001-2006) and started my PhD in the field of Proteomics at the Rudolf-Virchow Institute at Würzburg (coop. with the University of Würzburg). I finished my PhD (2011) at the Leibniz-Institute at Dortmund (in coop. with technical university of Dortmund). Since 2010 I am with Merz starting as a scientific expert at the Quality Control department at Merz Pharma, Dessau. In 2015 I took over the role as the head of Quality Control. In 2021 I took over the responsibility of the QA Systems department in addition to the QC department. My QA team of ~60 employees is responsible for training, documentation, deviations, CAPA, change control, complaints, supplier, audits, technical QA for calibration/maintenance/qualification, internal project QA and adminstration of SAP QM / LIMS. My QC team handles incoming goods inspection of raw and packaging material, biochemical & physico-chemical in-process, release and stability testing of APIs and drug products as well as oversight of external laboratories for microbiological testing.

• 13:30 – 14:00

  Far UV-C Light - Safe and Effective Decontamination

  • Poster Presenter: Peter Tonning

    

    Peter Tonning
    

• 13:30 – 14:00

  Headspace Analysis as Innovative Method for Media Fill Inspection

  • Poster Presenter: Michael Mettraux

    

    Michael Mettraux
    

• 13:30 – 14:00

  Particle Loss in Transport Tubing: How to Address the New Annex 1 Requirement

  • Poster Presenter: Serena Steidl

    

    Serena Steidl
    

• 13:30 – 14:00

  Rapid Sterility Testing as the Critical and Final Result for Product Release - Design Verification (DV) Data

  • Poster Presenter: Johannes Oberdörfer, Field Application Scientist, Rapid Micro Biosystems

    

    Johannes Oberdörfer, Field Application Scientist, Rapid Micro Biosystems
    

    As a Field Application Scientist at Rapid Micro Biosystems, Johannes is responsible for the successful implementation of the Growth Direct System within companies across Europe. He is supporting customers during selection and successful implementation of state-of-the-art technologies in the microbiology routine labs. With this, his main task is to drive the transformation of the labs in terms of automation, innovation and digitalization. Johannes has worked across multiple disciplines along his career including Research and Development, Quality Control and Microbiology at Boehringer Ingelheim Pharma GmbH & Co.KG. Johannes holds a Bachelor’s Degree in Process Engineering Biopharmaceuticals by the University of Applied Sciences, Bingen, Germany.

• 13:30 – 14:00

  Reducing Glove Intervention in Fill & Finish Process

  • Poster Presenter: Patrick Wieland

    

    Patrick Wieland
    

• 13:30 – 14:00

  VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products

  • Poster Presenter: Dilara Ali, MSc, PhD Student , ten23 health

    

    Dilara Ali, MSc, PhD Student , ten23 health
    

    Dilara Ali is a Ph.D. Student in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics, from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Freiburg. During her masters, alongside her studies, she worked on the development of liquid formulations. Her master's thesis investigated single-use material used during aseptic manufacturing. Currently pursuing her Ph.D., she focuses on optimizing disposable manufacturing material in fill-finish operations.

Session 1, Track A: Impact of EU GMP Annex 1 on Lyophilization

Alte Stuttgarter Reithalle

• Moderator: Andrea Salmaso, PharmD, Corporate Regulatory and Scientific Affairs Manager, Stevanato Group

  

  Andrea Salmaso, PharmD, Corporate Regulatory and Scientific Affairs Manager, Stevanato Group
  

  Andrea Salmaso is a Pharmacist with Master Degree reached in 1999 at Padua University. He has 24 years of experience in Compliance and Regulatory Affairs in pharmaceutical and Medical Devices industries. He has collaborated with the Departments of Physiology, Pharmacology and Biology of the University of Padova. He has worked as Quality Assurance Manager and Qualified Person (Directive 2001/83/EC) for two Italian Pharmaceutical Industries. He has been working in Stevanato Group Spa since 2007 in Quality Assurance Department as Corporate Regulatory & Scientific Affairs Manager. Currently, is responsible for overseeing and coordinating Stevanato Group Regulatory activities across Drug Container Systems. He is memebr of ISO Tecnical Commity TC76 WG2 and co-author of PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications.

• 14:00 – 14:25

  Requirements for Lyophilization in the New Annex 1

  • Regulatory Presenter: Marisa Delbo, PharmD, Consultant , NA

    

    Marisa Delbo, PharmD, Consultant , NA
    

    Marisa Delbò is a pharmacist, graduated summa cum laude and specialized in “Chemistry and Technology of natural organic substances”. After about 5 years of experience in private and public pharmacies, she carried out full time activity of study and research at the University “La Sapienza” of Rome. In 1995 she started working at the Ministry of Health as an assessor and a GMP inspector and continued her activity as a senior GMP inspector at the Italian Medicines Agency, AIFA, when the Agency was established in 2004. She was Head of various AIFA Offices: Product Quality Office, GMP inspectorate, Risk Management Office and GMP Inspections and Manufacturing Authorizations of APIs Office. She was a member of several national and international committees and working groups, assessor of the certification of suitability of the European Pharmacopoeia, Italian representative in the PIC/S Committee and Deputy-chair in the PIC/S Subcommittee on Harmonization and in the PIC/S Subcommitteee on Expert Circles, Vice-Chair and then Chair of the EMA Committee for Herbal Medicinal Products and Vice-Chair of the EMA Working Party on Community Monographs and Community List. Marisa Delbò was Rapporteur for several European guidance documents, HMPC Rapporteur of the revision of annex 7 of the EU GMP, Rapporteur and peer-reviewer for many EU herbal monographs. She published 5 articles on international peer-reviewed journals and provided several contributions to congresses and national publications. After her retirement on 2021 April the 1st she continued to cooperate with AIFA and to be the Chair of the PIC/S Expert Circle on Human Blood, Tissues & Cells and ATMPs and the de facto Member of the PIC/S Sub- Committee on Expert Circles. She is currently a teacher in Seminars, Masters and training courses on GMP inspections and has a contract as an external senior GMP inspector with the Maltese Medicines Agency..

• 14:25 – 14:50

  A Better Approach to APS for Lyophilized Products - APS Approach for Freeze-Drying Process Considering Annex 1 Requirements

  • Presenter: Christian Scarpato, Process Engineering Manager, Merck

    

    Christian Scarpato, Process Engineering Manager, Merck
    

    He is a sterile engineering expert with almost 13 years of experience in pharma companies (sterile and non-sterile manufacturing site). He worked on greenfield projects into the design, installation, and start-up phases in Baxter, GSK and Merck and into day-by-day technical support and on improvment. Recently He worked on three new sterile production lines (vials, cartridges, and syringes) with cutting-edge technology (isolator technology) and advanced automation (SCADA and MES driven manufacturing processes) in Merck Bari site. He currently leads the process engineering team in Merck Bari. He graduated with honours in Chemical Engineering from Federico II University of Naples.

• 14:50 – 15:20

  Q&A, Discussion

  • Moderator: Andrea Salmaso, PharmD, Corporate Regulatory and Scientific Affairs Manager, Stevanato Group

    

    Andrea Salmaso, PharmD, Corporate Regulatory and Scientific Affairs Manager, Stevanato Group
    

    Andrea Salmaso is a Pharmacist with Master Degree reached in 1999 at Padua University. He has 24 years of experience in Compliance and Regulatory Affairs in pharmaceutical and Medical Devices industries. He has collaborated with the Departments of Physiology, Pharmacology and Biology of the University of Padova. He has worked as Quality Assurance Manager and Qualified Person (Directive 2001/83/EC) for two Italian Pharmaceutical Industries. He has been working in Stevanato Group Spa since 2007 in Quality Assurance Department as Corporate Regulatory & Scientific Affairs Manager. Currently, is responsible for overseeing and coordinating Stevanato Group Regulatory activities across Drug Container Systems. He is memebr of ISO Tecnical Commity TC76 WG2 and co-author of PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications.

  • Panelist: Marisa Delbo, PharmD, Consultant , NA

    

    Marisa Delbo, PharmD, Consultant , NA
    

    Marisa Delbò is a pharmacist, graduated summa cum laude and specialized in “Chemistry and Technology of natural organic substances”. After about 5 years of experience in private and public pharmacies, she carried out full time activity of study and research at the University “La Sapienza” of Rome. In 1995 she started working at the Ministry of Health as an assessor and a GMP inspector and continued her activity as a senior GMP inspector at the Italian Medicines Agency, AIFA, when the Agency was established in 2004. She was Head of various AIFA Offices: Product Quality Office, GMP inspectorate, Risk Management Office and GMP Inspections and Manufacturing Authorizations of APIs Office. She was a member of several national and international committees and working groups, assessor of the certification of suitability of the European Pharmacopoeia, Italian representative in the PIC/S Committee and Deputy-chair in the PIC/S Subcommittee on Harmonization and in the PIC/S Subcommitteee on Expert Circles, Vice-Chair and then Chair of the EMA Committee for Herbal Medicinal Products and Vice-Chair of the EMA Working Party on Community Monographs and Community List. Marisa Delbò was Rapporteur for several European guidance documents, HMPC Rapporteur of the revision of annex 7 of the EU GMP, Rapporteur and peer-reviewer for many EU herbal monographs. She published 5 articles on international peer-reviewed journals and provided several contributions to congresses and national publications. After her retirement on 2021 April the 1st she continued to cooperate with AIFA and to be the Chair of the PIC/S Expert Circle on Human Blood, Tissues & Cells and ATMPs and the de facto Member of the PIC/S Sub- Committee on Expert Circles. She is currently a teacher in Seminars, Masters and training courses on GMP inspections and has a contract as an external senior GMP inspector with the Maltese Medicines Agency..

  • Panelist: Christian Scarpato, Process Engineering Manager, Merck

    

    Christian Scarpato, Process Engineering Manager, Merck
    

    He is a sterile engineering expert with almost 13 years of experience in pharma companies (sterile and non-sterile manufacturing site). He worked on greenfield projects into the design, installation, and start-up phases in Baxter, GSK and Merck and into day-by-day technical support and on improvment. Recently He worked on three new sterile production lines (vials, cartridges, and syringes) with cutting-edge technology (isolator technology) and advanced automation (SCADA and MES driven manufacturing processes) in Merck Bari site. He currently leads the process engineering team in Merck Bari. He graduated with honours in Chemical Engineering from Federico II University of Naples.

Session 1, Track B: Sustainability in Aseptic Manufacturing

• Moderator: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

  

  Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK
  

  Paul Devuyst Senior Manager Aspetic Technologies, GSK Global MSAT Master Degree Bioengineer and 3rd cycle in Pharmaceutical Engineering. Expertise in engineering and project management, mainly in biotech and pharmaceutical projects, Profound experience in managing designs and leading projects during project delivery until verification step. Manage multidisciplinary teams knowledgeable about GEP, Aseptic processes, clean utility systems, process equipment and facility design. Aseptic and sterile manufacturing and containment solutions As Senior Manager Aseptic Technologies, act as global technology (equipment and associated practices) owner for GSK Vaccines in Secondary Aseptic Technologies (from formulation container to primary container capping - vials, syringes, tubes, BFS – in RABS, Isolator Technologies, loading / unloading of Freeze-dryers ) Whatever the expertise area managed by each Global experts, articulated around 7 Core Activities: o Technical Standard o Project support o Global Support and Troubleshooting support o Capacity and performance monitoring o Site capability development o Technologies Intelligence (TRD, RA, Commercial interface) o Technical watch

• 14:00 – 14:25

  From Sustainability Ambitions into Action: What About Aseptic Manufacturing?

  • Presenter: Michael Hell, PhD, Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA

    

    Michael Hell, PhD, Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA
    

    Dr. Michael Hell is heading environment & sustainability at Merck Healthcare Operations. In his professional career, he gathered substantial experience in manufacturing and operations of (bio)pharmaceuticals as EHS business lead, production manager, head of strategy realization, and consultant. Michael is a chemist (Dipl-Chem., TU Munich) and cell biologist (PhD, ETH Zurich) by education. He is an active member in industry associations, conference track lead / speaker and co-author of scientific papers or book chapters. Michael is passionate for sustainability also in private life, footprint decreases year after year.

• 14:25 – 14:50

  Can We Have Reliable and Fast Sustainability Impact Assessments? Merging Technology, Innovation, and Sustainability

  • Presenter: Alissa Monk, Sustainability Lead , ten23 health

    

    Alissa Monk, Sustainability Lead , ten23 health
    

    Alissa Monk is currently working as a Sustainability Lead at ten23 health and was previously an Environmental Sustainability Lead in the research department at Novartis. She is an executive member of ‘Go Circular in Life Sciences’ and a steering committee member for My Green Lab. She has a background as an environmental scientist, more specifically ecotoxicology. She pushes for collaborative action to address systemic issues and is passionate about understanding and measuring environmental impact, and creating tools and automated processes to help accelerate sustainable action.

• 14:50 – 15:20

  Q&A, Discussion

  • Moderator: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

    

    Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK
    

    Paul Devuyst Senior Manager Aspetic Technologies, GSK Global MSAT Master Degree Bioengineer and 3rd cycle in Pharmaceutical Engineering. Expertise in engineering and project management, mainly in biotech and pharmaceutical projects, Profound experience in managing designs and leading projects during project delivery until verification step. Manage multidisciplinary teams knowledgeable about GEP, Aseptic processes, clean utility systems, process equipment and facility design. Aseptic and sterile manufacturing and containment solutions As Senior Manager Aseptic Technologies, act as global technology (equipment and associated practices) owner for GSK Vaccines in Secondary Aseptic Technologies (from formulation container to primary container capping - vials, syringes, tubes, BFS – in RABS, Isolator Technologies, loading / unloading of Freeze-dryers ) Whatever the expertise area managed by each Global experts, articulated around 7 Core Activities: o Technical Standard o Project support o Global Support and Troubleshooting support o Capacity and performance monitoring o Site capability development o Technologies Intelligence (TRD, RA, Commercial interface) o Technical watch

  • Panelist: Michael Hell, PhD, Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA

    

    Michael Hell, PhD, Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA
    

    Dr. Michael Hell is heading environment & sustainability at Merck Healthcare Operations. In his professional career, he gathered substantial experience in manufacturing and operations of (bio)pharmaceuticals as EHS business lead, production manager, head of strategy realization, and consultant. Michael is a chemist (Dipl-Chem., TU Munich) and cell biologist (PhD, ETH Zurich) by education. He is an active member in industry associations, conference track lead / speaker and co-author of scientific papers or book chapters. Michael is passionate for sustainability also in private life, footprint decreases year after year.

  • Panelist: Alissa Monk, Sustainability Lead , ten23 health

    

    Alissa Monk, Sustainability Lead , ten23 health
    

    Alissa Monk is currently working as a Sustainability Lead at ten23 health and was previously an Environmental Sustainability Lead in the research department at Novartis. She is an executive member of ‘Go Circular in Life Sciences’ and a steering committee member for My Green Lab. She has a background as an environmental scientist, more specifically ecotoxicology. She pushes for collaborative action to address systemic issues and is passionate about understanding and measuring environmental impact, and creating tools and automated processes to help accelerate sustainable action.

Networking Coffee Break, Poster Session & Exhibition

Saal MARITIM & Lobby Empore

Session 2, Track A: Filtration and Closed Systems

Alte Stuttgarter Reithalle

• Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

  

  Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON
  

  Peter has over 19 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how. Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Advanced Manufacturing and Applied Process Digitalization IG, and Mobile Manufacturing Task Force.

• 15:50 – 16:15

  PUPSIT in the Revised Annex I – Friend or Foe of the Pharmaceutical Entrepreneur?

  • Presenter: Manuel Grund, Process Engineer, Roche Pharmaceuticals

    

    Manuel Grund, Process Engineer, Roche Pharmaceuticals
    

    Mr. Manuel Grund works for Roche's Pharmaceutical Division in the role of process engineer in Mannheim, Germany, holding a degree as state-certified chemical engineer. During his early professional years in the chemical industry, he accompanied pilot as well as large-scale manufacturing processes for the synthesis of organic and inorganic fluorine compounds for over a decade. With his move to Roche in 2016, Mr. Grund initially took a leadership role in the cGMP-regulated parenteral production of prefilled syringes. From 2018 to 2021, he supervised the aseptic drug product manufacturing of several biologics and small molecules in glass vials on a multi-purpose line for lyophilisates & liquids from a Manufacturing Science and Technology perspective. In addi-tion to root cause analyses and product quality impact assessments, his focus was on optimization projects relating to process robustness. He specialized in the areas of sterile filtration / filter integrity testing, glass fractography and cGMP auditing. Since 2021, Mr. Grund has been developing and validating preparation and tray filling processes in silicone-free COP primary packaging for parenteral launches. He is also responsible for the design conception and qualification of single-use systems. His ongoing studies in industrial pharmacy complement his profile.

• 16:15 – 16:40

  Contamination Control Strategies in Processing of Frozen Sterile Bulk Drug Product in Single-use Bag Assembly

  • Presenter: Yuan-An Liu, PhD, Associate Director CMC, BioNTech SE

    

    Yuan-An Liu, PhD, Associate Director CMC, BioNTech SE
    

    Yuan-An Liu works as an Associate Director CMC in the Technical Development department of BioNTech SE. He is a subject matter expert for late-stage development of manufacturing process for sterile injectables which includes small molecule, mRNA based products and ADCs. His current focus is development of scalable and compliant aseptic processes including processing of (sterile) bulk drug product, sterilizing filtration, aseptic filling and lyophilization.

• 16:40 – 17:10

  Q&A, Discussion

  • Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

    

    Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON
    

    Peter has over 19 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how. Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Advanced Manufacturing and Applied Process Digitalization IG, and Mobile Manufacturing Task Force.

  • Panelist: Manuel Grund, Process Engineer, Roche Pharmaceuticals

    

    Manuel Grund, Process Engineer, Roche Pharmaceuticals
    

    Mr. Manuel Grund works for Roche's Pharmaceutical Division in the role of process engineer in Mannheim, Germany, holding a degree as state-certified chemical engineer. During his early professional years in the chemical industry, he accompanied pilot as well as large-scale manufacturing processes for the synthesis of organic and inorganic fluorine compounds for over a decade. With his move to Roche in 2016, Mr. Grund initially took a leadership role in the cGMP-regulated parenteral production of prefilled syringes. From 2018 to 2021, he supervised the aseptic drug product manufacturing of several biologics and small molecules in glass vials on a multi-purpose line for lyophilisates & liquids from a Manufacturing Science and Technology perspective. In addi-tion to root cause analyses and product quality impact assessments, his focus was on optimization projects relating to process robustness. He specialized in the areas of sterile filtration / filter integrity testing, glass fractography and cGMP auditing. Since 2021, Mr. Grund has been developing and validating preparation and tray filling processes in silicone-free COP primary packaging for parenteral launches. He is also responsible for the design conception and qualification of single-use systems. His ongoing studies in industrial pharmacy complement his profile.

  • Panelist: Yuan-An Liu, PhD, Associate Director CMC, BioNTech SE

    

    Yuan-An Liu, PhD, Associate Director CMC, BioNTech SE
    

    Yuan-An Liu works as an Associate Director CMC in the Technical Development department of BioNTech SE. He is a subject matter expert for late-stage development of manufacturing process for sterile injectables which includes small molecule, mRNA based products and ADCs. His current focus is development of scalable and compliant aseptic processes including processing of (sterile) bulk drug product, sterilizing filtration, aseptic filling and lyophilization.

Session 2, Track B: Aseptic Set-Up of Filling Machines

• Moderator: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

  

  Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
  

  Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers.

• 15:50 – 16:15

  Implementing Annex 1 Guidelines: A Comprehensive Approach to Sterility Assurance for Indirect Product Contact Parts

  • Presenter: Christian Rust, B.S. Chemical and Biomolecular Engineering, Technical Operations, MSD

    

    Christian Rust, B.S. Chemical and Biomolecular Engineering, Technical Operations, MSD
    

    Christian graduated from North Carolina State University with degrees in Chemical and Biomolecular Engineering and Textile Engineering and currently works at MSD in Durham, North Carolina on a facility start-up with responsibility over the drug product filling line. In 2019, he joined MSD’s Manufacturing Leadership Development Program where he held positions with MSD in vaccine manufacturing support, process engineering, and was a process development scientist working with monoclonal antibodies.

• 16:15 – 16:40

  Compliance with New Annex 1 on a Fill/Finish Machine: A Glance into the Future

  • Presenter: Helen Sauter, Dr, Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG

    

    Helen Sauter, Dr, Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG
    

    Dr. Helen Sauter, Director QA - Sterility Assurance/Lab Operation/Training Systems Hold a degree in microbiology, working for Vetter Pharma since 2013. Experienced in the fields of aseptic process validation, gowning qualification, contamination control strategy, QA for QC and pharmaceutical GMP-training including presention of these topics during audits and regulatory inspections.

• 16:40 – 17:10

  Q&A, Discussion

  • Moderator: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

    

    Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
    

    Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers.

  • Panelist: Christian Rust, B.S. Chemical and Biomolecular Engineering, Technical Operations, MSD

    

    Christian Rust, B.S. Chemical and Biomolecular Engineering, Technical Operations, MSD
    

    Christian graduated from North Carolina State University with degrees in Chemical and Biomolecular Engineering and Textile Engineering and currently works at MSD in Durham, North Carolina on a facility start-up with responsibility over the drug product filling line. In 2019, he joined MSD’s Manufacturing Leadership Development Program where he held positions with MSD in vaccine manufacturing support, process engineering, and was a process development scientist working with monoclonal antibodies.

  • Panelist: Helen Sauter, Dr, Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG

    

    Helen Sauter, Dr, Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG
    

    Dr. Helen Sauter, Director QA - Sterility Assurance/Lab Operation/Training Systems Hold a degree in microbiology, working for Vetter Pharma since 2013. Experienced in the fields of aseptic process validation, gowning qualification, contamination control strategy, QA for QC and pharmaceutical GMP-training including presention of these topics during audits and regulatory inspections.

End of Conference Day 1 & Networking Event

Registration Open

Session 3, Track A: Environmental Monitoring

Alte Stuttgarter Reithalle

• Moderator: Hue Kwon, PhD, Advisory consultant, GLS Advisors LLC

  

  Hue Kwon, PhD, Advisory consultant, GLS Advisors LLC
  

  Dr. Hue Kwon has been advising and consulting internationally as a senior advisor consultant on GxP quality maturity and digital transformation for various pharma/biotech organizations. She has over 20 years of experience in GxP quality and regulatory strategies from working within the biopharmaceutical industry including being a Vice President and Quality Team Leader at Samsung Bioepis providing GxP quality and compliance oversight for the end-to-end drug development and lifecycle and being the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus. Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.

• 09:00 – 09:20

  Total Particle Count – Tubing Qualification at GSK: Lessons Learned

  • Co-Presenter: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

    

    Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK
    

    Paul Devuyst Senior Manager Aspetic Technologies, GSK Global MSAT Master Degree Bioengineer and 3rd cycle in Pharmaceutical Engineering. Expertise in engineering and project management, mainly in biotech and pharmaceutical projects, Profound experience in managing designs and leading projects during project delivery until verification step. Manage multidisciplinary teams knowledgeable about GEP, Aseptic processes, clean utility systems, process equipment and facility design. Aseptic and sterile manufacturing and containment solutions As Senior Manager Aseptic Technologies, act as global technology (equipment and associated practices) owner for GSK Vaccines in Secondary Aseptic Technologies (from formulation container to primary container capping - vials, syringes, tubes, BFS – in RABS, Isolator Technologies, loading / unloading of Freeze-dryers ) Whatever the expertise area managed by each Global experts, articulated around 7 Core Activities: o Technical Standard o Project support o Global Support and Troubleshooting support o Capacity and performance monitoring o Site capability development o Technologies Intelligence (TRD, RA, Commercial interface) o Technical watch

  • Co-Presenter: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

    

    Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
    

    Kurt Jaecques is the Global Aseptic Technologies lead for Monitoring and Control at GSK and has been working within the pharmaceutical Industry for more than 30 years. He holds a Master's degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, Bioburden Controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the PDA TR13 on Environmental Monitoring and is PDA IG co-lead for Microbiology and Environmental Monitoring.

• 09:20 – 09:40

  How to Collect All EM Data and Doing Computerized Trending Without Entering the Data Manually

  • Co-Presenter: Marc M. Machauer, OEM Coordinator, Particle Measuring Systems

    

    Marc M. Machauer, OEM Coordinator, Particle Measuring Systems
    

    Particle Measuring Systems 5 yrs 1 mo5 yrs 1 mo OEM CoordinatorOEM Coordinator Full-timeFull-time Mar 2021 - Present · 3 yrs 1 moMar 2021 - Present · 3 yrs 1 mo Baden-Württemberg, GermanyBaden-Württemberg, Germany Sales ManagerSales Manager Mar 2019 - Feb 2021 · 2 yrsMar 2019 - Feb 2021 · 2 yrs South GermanySouth Germany OPTIMA packaging group logo Sales Manager OPTIMA packaging group GmbH Aug 2006 - Feb 2019 · 12 yrs 7 mosAug 2006 - Feb 2019 · 12 yrs 7 mos Schwäbisch HallSchwäbisch Hall ADICAL INC Sales and Service Manager ADICAL INC Sep 2001 - Aug 2006 · 5 yrsSep 2001 - Aug 2006 · 5 yrs Greater San Diego AreaGreater San Diego Area Responsible for sales and service of Bausch and Stroebel equipment in the Western USA.Responsible for sales and service of Bausch and Stroebel equipment in the Western USA. Bausch+Ströbel SE + Co. KG logo from mechanical apprentise to sales manager Bausch+Ströbel SE + Co. KGBausch+Ströbel SE + Co. KG Sep 1994 - Sep 2001 · 7 yrs 1 moSep 1994 - Sep 2001 · 7 yrs 1 mo Ilshofen, Germany (Head Quarters of Bausch and Stroebel) · On-site Started in 1994 as an apprentice for industrial engineering. Graduated in 1998. Started in 1998 as an apprentice for business and administration. Graduated in 2000. Worked in the Sales Organization. Created documents to support the sales force. Started the technical training project for customers and business partner.

  • Co-Presenter: Susan B. Cleary, EMBA, Director of Product Development, Novatek International

    

    Susan B. Cleary, EMBA, Director of Product Development, Novatek International
    

    Susan B. Cleary, B.CS, EMBA. is the Director of Product Development at Novatek International. Susan has almost 25 years of experience in designing, developing, and implementing large scale quality management and contamination control systems. Susan works with pharmaceutical, biotech, and medical device companies and specializes in data integrity and regulatory compliance for cleanroom control and is highly experienced with streamlining quality processes and digitalizing data for GMP and Annex 1 compliant systems dedicated to Cleaning Validation, Environmental Monitoring, and Utility Monitoring.

• 09:40 – 10:00

  Automated Reading of Agar Plates Using AI and Machine Learning

  • Presenter: Andrew Gravett, Principal Scientist Microbiology, AstraZeneca

    

    Andrew Gravett, Principal Scientist Microbiology, AstraZeneca
    

    Mr Andrew Gravett, Principal Scientist- Microbiology in Pharmaceutical Technology and Development (PT&D) AstraZeneca Cheshire Campus, Macclesfield UK. Employed in the Pharmaceutical Industry in the North West of England since 1987. Microbiologist by qualification and employed in QA/QC functions at manufacturing facility operations from 1987-2012. Gained experience in Microbiology QC and QA functions, Water systems specialist, and Aseptic Manufacturing. Experience in several roles within AstraZeneca's Global Quality Audit Function from 2012-2020 performing Quality audits of Contract Manufacturers, Suppliers and Marketing Organisations. Achieved IRCA Certification as a Lead Auditor of Pharmaceutical Quality Management System. Currently role involves evaluating, proof of concept and validation of new and novel 'microbiological' technologies for use in QC microbiology and processing.

• 10:00 – 10:30

  Q&A, Discussion

  • Moderator: Hue Kwon, PhD, Advisory consultant, GLS Advisors LLC

    

    Hue Kwon, PhD, Advisory consultant, GLS Advisors LLC
    

    Dr. Hue Kwon has been advising and consulting internationally as a senior advisor consultant on GxP quality maturity and digital transformation for various pharma/biotech organizations. She has over 20 years of experience in GxP quality and regulatory strategies from working within the biopharmaceutical industry including being a Vice President and Quality Team Leader at Samsung Bioepis providing GxP quality and compliance oversight for the end-to-end drug development and lifecycle and being the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus. Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.

  • Panelist: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

    

    Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK
    

    Paul Devuyst Senior Manager Aspetic Technologies, GSK Global MSAT Master Degree Bioengineer and 3rd cycle in Pharmaceutical Engineering. Expertise in engineering and project management, mainly in biotech and pharmaceutical projects, Profound experience in managing designs and leading projects during project delivery until verification step. Manage multidisciplinary teams knowledgeable about GEP, Aseptic processes, clean utility systems, process equipment and facility design. Aseptic and sterile manufacturing and containment solutions As Senior Manager Aseptic Technologies, act as global technology (equipment and associated practices) owner for GSK Vaccines in Secondary Aseptic Technologies (from formulation container to primary container capping - vials, syringes, tubes, BFS – in RABS, Isolator Technologies, loading / unloading of Freeze-dryers ) Whatever the expertise area managed by each Global experts, articulated around 7 Core Activities: o Technical Standard o Project support o Global Support and Troubleshooting support o Capacity and performance monitoring o Site capability development o Technologies Intelligence (TRD, RA, Commercial interface) o Technical watch

  • Panelist: Marc M. Machauer, OEM Coordinator, Particle Measuring Systems

    

    Marc M. Machauer, OEM Coordinator, Particle Measuring Systems
    

    Particle Measuring Systems 5 yrs 1 mo5 yrs 1 mo OEM CoordinatorOEM Coordinator Full-timeFull-time Mar 2021 - Present · 3 yrs 1 moMar 2021 - Present · 3 yrs 1 mo Baden-Württemberg, GermanyBaden-Württemberg, Germany Sales ManagerSales Manager Mar 2019 - Feb 2021 · 2 yrsMar 2019 - Feb 2021 · 2 yrs South GermanySouth Germany OPTIMA packaging group logo Sales Manager OPTIMA packaging group GmbH Aug 2006 - Feb 2019 · 12 yrs 7 mosAug 2006 - Feb 2019 · 12 yrs 7 mos Schwäbisch HallSchwäbisch Hall ADICAL INC Sales and Service Manager ADICAL INC Sep 2001 - Aug 2006 · 5 yrsSep 2001 - Aug 2006 · 5 yrs Greater San Diego AreaGreater San Diego Area Responsible for sales and service of Bausch and Stroebel equipment in the Western USA.Responsible for sales and service of Bausch and Stroebel equipment in the Western USA. Bausch+Ströbel SE + Co. KG logo from mechanical apprentise to sales manager Bausch+Ströbel SE + Co. KGBausch+Ströbel SE + Co. KG Sep 1994 - Sep 2001 · 7 yrs 1 moSep 1994 - Sep 2001 · 7 yrs 1 mo Ilshofen, Germany (Head Quarters of Bausch and Stroebel) · On-site Started in 1994 as an apprentice for industrial engineering. Graduated in 1998. Started in 1998 as an apprentice for business and administration. Graduated in 2000. Worked in the Sales Organization. Created documents to support the sales force. Started the technical training project for customers and business partner.

  • Panelist: Andrew Gravett, Principal Scientist Microbiology, AstraZeneca

    

    Andrew Gravett, Principal Scientist Microbiology, AstraZeneca
    

    Mr Andrew Gravett, Principal Scientist- Microbiology in Pharmaceutical Technology and Development (PT&D) AstraZeneca Cheshire Campus, Macclesfield UK. Employed in the Pharmaceutical Industry in the North West of England since 1987. Microbiologist by qualification and employed in QA/QC functions at manufacturing facility operations from 1987-2012. Gained experience in Microbiology QC and QA functions, Water systems specialist, and Aseptic Manufacturing. Experience in several roles within AstraZeneca's Global Quality Audit Function from 2012-2020 performing Quality audits of Contract Manufacturers, Suppliers and Marketing Organisations. Achieved IRCA Certification as a Lead Auditor of Pharmaceutical Quality Management System. Currently role involves evaluating, proof of concept and validation of new and novel 'microbiological' technologies for use in QC microbiology and processing.

  • Panelist: Susan B. Cleary, EMBA, Director of Product Development, Novatek International

    

    Susan B. Cleary, EMBA, Director of Product Development, Novatek International
    

    Susan B. Cleary, B.CS, EMBA. is the Director of Product Development at Novatek International. Susan has almost 25 years of experience in designing, developing, and implementing large scale quality management and contamination control systems. Susan works with pharmaceutical, biotech, and medical device companies and specializes in data integrity and regulatory compliance for cleanroom control and is highly experienced with streamlining quality processes and digitalizing data for GMP and Annex 1 compliant systems dedicated to Cleaning Validation, Environmental Monitoring, and Utility Monitoring.

Session 3, Track B: Equipment for Aseptic Processes

• Moderator: Tracy Moore, Director, TM Pharma Group Ltd

  

  Tracy Moore, Director, TM Pharma Group Ltd
  

  Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• 09:00 – 09:20

  Annex 1 and 'Good Technology Practice' - Interpretation and Engineering for This Side of Production

  • Presenter: Johannes M. Rauschnabel, PhD, Director Advanced Technology Development and Innovation, Syntegon Technology GmbH

    

    Johannes M. Rauschnabel, PhD, Director Advanced Technology Development and Innovation, Syntegon Technology GmbH
    

    Johannes Rauschnabel is a studied chemist with a PhD from Tuebingen University. Johannes has 25 years of experience in pharma packaging with roles in product management for barrier systems, as a team lead in process development, as a Chief Pharma Expert for the business unit and actually: as a director Advanced Technology Development and Innovation at Syntegon Technology GmbH (former Bosch Packaging) in Waiblingen/Germany. Johannes holds a variety of patents, has published many scientific papers and is a frequent speaker at Pharma events including PDA conferences.

• 09:20 – 09:40

  Critical Factors in the Material Transfer Process

  • Presenter: Anna Campanella, PhD, Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG

    

    Anna Campanella, PhD, Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG
    

    Anna Campanella holds a Ph.D. in Molecular Medicine and boasts 17 years of experience in the pharmaceutical industry. She began her journey in microbiological and biochemical laboratories, specializing in sterile injectable products and aseptic production processes. Over the years, she took on pivotal roles, including QA&QC Manager and Global Head of Sterility Assurance, increasing her experience using QRM and QbD methodologies. Anna's expertise spans microbiological and particle impact assessments in pharmaceutical processes, and she is renowned for crafting advanced Contamination Control Strategies. Her unwavering commitment to quality and safety defines her legacy in the pharmaceutical world.

• 09:40 – 10:00

  Disinfection and Material Intake Programs – Implementation, Challenges and Solutions

  • Presenter: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    

    David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences
    

    David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing. David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilised and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents. David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilising robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding). In his current role David works with customers on devising the most efficient and robust cleanroom disinfection strategy. He also works with customers on their environmental monitoring programs, water systems and regulatory compliance.

• 10:00 – 10:30

  Q&A, Discussion

  • Moderator: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

  • Panelist: Anna Campanella, PhD, Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG

    

    Anna Campanella, PhD, Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG
    

    Anna Campanella holds a Ph.D. in Molecular Medicine and boasts 17 years of experience in the pharmaceutical industry. She began her journey in microbiological and biochemical laboratories, specializing in sterile injectable products and aseptic production processes. Over the years, she took on pivotal roles, including QA&QC Manager and Global Head of Sterility Assurance, increasing her experience using QRM and QbD methodologies. Anna's expertise spans microbiological and particle impact assessments in pharmaceutical processes, and she is renowned for crafting advanced Contamination Control Strategies. Her unwavering commitment to quality and safety defines her legacy in the pharmaceutical world.

  • Panelist: Johannes M. Rauschnabel, PhD, Director Advanced Technology Development and Innovation, Syntegon Technology GmbH

    

    Johannes M. Rauschnabel, PhD, Director Advanced Technology Development and Innovation, Syntegon Technology GmbH
    

    Johannes Rauschnabel is a studied chemist with a PhD from Tuebingen University. Johannes has 25 years of experience in pharma packaging with roles in product management for barrier systems, as a team lead in process development, as a Chief Pharma Expert for the business unit and actually: as a director Advanced Technology Development and Innovation at Syntegon Technology GmbH (former Bosch Packaging) in Waiblingen/Germany. Johannes holds a variety of patents, has published many scientific papers and is a frequent speaker at Pharma events including PDA conferences.

  • Panelist: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    

    David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences
    

    David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing. David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilised and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents. David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilising robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding). In his current role David works with customers on devising the most efficient and robust cleanroom disinfection strategy. He also works with customers on their environmental monitoring programs, water systems and regulatory compliance.

Networking Coffee Break, Poster Session & Exhibition

Saal MARITIM & Lobby Empore

Session 4, Track A: Quality Risk Management

Alte Stuttgarter Reithalle

• Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

  

  Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
  

  Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

• 11:00 – 11:25

  A Matter of Uncertainty: Risk Tool Selection With ICH Q9(R1) In Mind

  • Presenter: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    

    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  [email protected].

• 11:25 – 11:50

  Using Risk Management to Design Aseptic Process Simulations

  • Presenter: Alberto Gonzalez, Global Sterility Assurance Associate Director, Takeda

    

    Alberto Gonzalez, Global Sterility Assurance Associate Director, Takeda
    

    Alberto is a pharmacist with 14 years of multinational experience in the pharma and biotech industries. In his first roles he was responsible for Quality Assurance, Quality Systems and Quality Compliance for sterile products. In his current position with Takeda’s Global Sterility Assurance and Microbiology team he has had a pivotal role on the company-wide implementation of Annex 1. His expertise lies with Aseptic Process Simulations, Contamination Control Strategies and application of Quality Risk Management to aseptic production. This can be summarized in his motto: “Think Aseptic”. He is an invited speaker at industry conferences and is active in industry collaborations.

• 11:50 – 12:20

  Q&A, Discussion

  • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    

    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
    

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

  • Panelist: Alberto Gonzalez, Global Sterility Assurance Associate Director, Takeda

    

    Alberto Gonzalez, Global Sterility Assurance Associate Director, Takeda
    

    Alberto is a pharmacist with 14 years of multinational experience in the pharma and biotech industries. In his first roles he was responsible for Quality Assurance, Quality Systems and Quality Compliance for sterile products. In his current position with Takeda’s Global Sterility Assurance and Microbiology team he has had a pivotal role on the company-wide implementation of Annex 1. His expertise lies with Aseptic Process Simulations, Contamination Control Strategies and application of Quality Risk Management to aseptic production. This can be summarized in his motto: “Think Aseptic”. He is an invited speaker at industry conferences and is active in industry collaborations.

  • Panelist: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    

    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  [email protected].

Session 4, Track B: RABS/Isolator

• Moderator: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

  

  David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences
  

  David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing. David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilised and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents. David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilising robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding). In his current role David works with customers on devising the most efficient and robust cleanroom disinfection strategy. He also works with customers on their environmental monitoring programs, water systems and regulatory compliance.

• 11:00 – 11:25

  Pre-Validation of a Gloveless Isolator Filling Line - Experience and Lessons Learned

  • Presenter: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH

    

    Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH
    

    Ms. Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Kiaserslautern. Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and as a manufacturing manager for parenteral applications, she was able to further deepen these skills. Since September 2014 she has been Head of Quality Control, since 2019 Managing Director of PharmBioTec GmbH, a non-profit research institute, and since 2020 Managing Director of PSM GmbH - a §13-AMG contract manufacturers for aseptic products.

• 11:25 – 11:50

  Leveraging Emerging Technologies for H2O2 Bio-Decontamination: From Novel Process Data to Real Process Impact

  • Presenter: Martin Novak, MSc, Technology Lead, SKAN AG

    

    Martin Novak, MSc, Technology Lead, SKAN AG
    

    Martin Novák, Technology lead at SKAN AG, is the bio-decontamination expert and aseptic processing visionary active for 10 years in R&D of hydrogen peroxide bio-decontamination and related technologies. Mr. Novák is a chemical technologist experienced is pharmaceutical isolator technology, where he provides technical support, guidance and scouting for his organization and its customers. Mr. Novák is a regular conference speaker and a member of ISO TC 198 and professional organizations such as PDA and ISPE. Following his BSc from University of Chemical Technology in Prague, Martin earned his MSc at the University of Applied Sciences FHNW in Switzerland, where he graduated with best-in-class honors.

• 11:50 – 12:20

  Q&A, Discussion

  • Moderator: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    

    David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences
    

    David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing. David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilised and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents. David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilising robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding). In his current role David works with customers on devising the most efficient and robust cleanroom disinfection strategy. He also works with customers on their environmental monitoring programs, water systems and regulatory compliance.

  • Panelist: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH

    

    Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH
    

    Ms. Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Kiaserslautern. Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and as a manufacturing manager for parenteral applications, she was able to further deepen these skills. Since September 2014 she has been Head of Quality Control, since 2019 Managing Director of PharmBioTec GmbH, a non-profit research institute, and since 2020 Managing Director of PSM GmbH - a §13-AMG contract manufacturers for aseptic products.

  • Panelist: Martin Novak, MSc, Technology Lead, SKAN AG

    

    Martin Novak, MSc, Technology Lead, SKAN AG
    

    Martin Novák, Technology lead at SKAN AG, is the bio-decontamination expert and aseptic processing visionary active for 10 years in R&D of hydrogen peroxide bio-decontamination and related technologies. Mr. Novák is a chemical technologist experienced is pharmaceutical isolator technology, where he provides technical support, guidance and scouting for his organization and its customers. Mr. Novák is a regular conference speaker and a member of ISO TC 198 and professional organizations such as PDA and ISPE. Following his BSc from University of Chemical Technology in Prague, Martin earned his MSc at the University of Applied Sciences FHNW in Switzerland, where he graduated with best-in-class honors.

Networking Lunch Break, Poster Session & Exhibition

Saal MARITIM & Lobby Empore

Interactive Questionnaire Session

Alte Stuttgarter Reithalle

Closing Plenary Part I

Alte Stuttgarter Reithalle

• Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

  

  Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc
  

  Darren has over 25 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems, he is an established SME for these processes, primarily focusing on Fedegari equipment. Darren is an established trainer and has delivered courses on industrial sterilization and autoclave operations across the world over the last 20years, Darren currently leads the Fedegari Technology Center in the US responsible for process consultancy focused on sterilization, decontamination, washing, associated aseptic processes and technical training.

• 13:30 – 13:40

  Excitement @Syntegon – Insights and Preparation for the Syntegon Factory Tour

  • Presenter: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

    

    Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
    

    Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers.

• 13:40 – 13:55

  Introduction of PDA Points to Consider (PtC) for Aseptic Filling

  • Presenter: Julian Petersen, Head of Business Development, groninger & co. gmbh

    

    Julian Petersen, Head of Business Development, groninger & co. gmbh
    

    Julian started his career in the pharma industry as a project manager at a German fill & finish system supplier. After a short time in the semiconductor business, Julian returned to the pharmaceutical fill & finish business as a Sales Director at groninger responsible for the DACH market. Now leading Business Development and Product Management, Julian is passionately focused on emerging and future technologies to meet the requirements of the vastly changing pharma industry. Julian is an active member of PDA (EU Co-Leader for the Sterile Processing Interest Group, PtC Aseptic Fill and Finish, PtC RABS) and ISPE.

• 13:55 – 14:15

  Evolution of GMPs and Why They Are Particularly Important for Sterile Manufacturing

  • Presenter: Andrew D Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    

    Andrew D Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
    

    Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companiese) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chair for the working group for the revision of Annex 1 • Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.

Networking Coffee Break, Poster Session & Exhibition

Saal MARITIM & Lobby Empore

Passport Raffle

Alte Stuttgarter Reithalle

• Moderator: Melanie Decker, Parenteral Drug Association

  

  Melanie Decker, Parenteral Drug Association
  

Closing Plenary Part II

Alte Stuttgarter Reithalle

• Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

  

  Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc
  

  Darren has over 25 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems, he is an established SME for these processes, primarily focusing on Fedegari equipment. Darren is an established trainer and has delivered courses on industrial sterilization and autoclave operations across the world over the last 20years, Darren currently leads the Fedegari Technology Center in the US responsible for process consultancy focused on sterilization, decontamination, washing, associated aseptic processes and technical training.

• 14:50 – 15:15

  Remote presentation title to be announced

  • Regulatory Presenter: Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA

    

    Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA
    

    Brooke K. Higgins is a Branch Chief for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for reviewing both international and domestic drug CGMP cases and supporting regulatory and enforcement actions and provides training to FDA investigators and compliance officers within CDER and ORA. She has served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued performing domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a MS in Food Science, focusing on food microbiology, and a BS in Biology from Virginia Tech.

• 15:15 – 15:40

  Updates on EU GMP Annex 1 - remote presentation -

  • Regulatory Presenter: Roberto Conocchia, MD, GMP Technical Lead, European Medicine Agency

    

    Roberto Conocchia, MD, GMP Technical Lead, European Medicine Agency
    

    Roberto Conocchia is a GMP Technical Lead at the European Medicine Agency (EMA) since March 2018. He obtained a Master degree in Bio-Chemistry from the University of Rome (La Sapienza) and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry. Roberto worked in three different API manufacturing sites in Italy from 2000 to 2006. He worked as GMP inspector at the Italian Agency Medicine (AIFA) performing regulatory inspections of pharmaceutical manufacturers (all dosage forms), focusing on sterile, not sterile and biological products from 2007 to 2018.

• 15:40 – 16:20

  Plenary Discussion

  • Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

    

    Simone Biel, PhD, Senior Regulatory Consultant, Merck
    

    Simone Biel is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing. She provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.

  • Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

    

    Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc
    

    Darren has over 25 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems, he is an established SME for these processes, primarily focusing on Fedegari equipment. Darren is an established trainer and has delivered courses on industrial sterilization and autoclave operations across the world over the last 20years, Darren currently leads the Fedegari Technology Center in the US responsible for process consultancy focused on sterilization, decontamination, washing, associated aseptic processes and technical training.

  • Panelist: Julian Petersen, Head of Business Development, groninger & co. gmbh

    

    Julian Petersen, Head of Business Development, groninger & co. gmbh
    

    Julian started his career in the pharma industry as a project manager at a German fill & finish system supplier. After a short time in the semiconductor business, Julian returned to the pharmaceutical fill & finish business as a Sales Director at groninger responsible for the DACH market. Now leading Business Development and Product Management, Julian is passionately focused on emerging and future technologies to meet the requirements of the vastly changing pharma industry. Julian is an active member of PDA (EU Co-Leader for the Sterile Processing Interest Group, PtC Aseptic Fill and Finish, PtC RABS) and ISPE.

  • Panelist: Andrew D Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    

    Andrew D Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
    

    Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companiese) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chair for the working group for the revision of Annex 1 • Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.

  • Panelist: Roberto Conocchia, MD, GMP Technical Lead, European Medicine Agency

    

    Roberto Conocchia, MD, GMP Technical Lead, European Medicine Agency
    

    Roberto Conocchia is a GMP Technical Lead at the European Medicine Agency (EMA) since March 2018. He obtained a Master degree in Bio-Chemistry from the University of Rome (La Sapienza) and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry. Roberto worked in three different API manufacturing sites in Italy from 2000 to 2006. He worked as GMP inspector at the Italian Agency Medicine (AIFA) performing regulatory inspections of pharmaceutical manufacturers (all dosage forms), focusing on sterile, not sterile and biological products from 2007 to 2018.

  • Panelist: Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA

    

    Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA}
    

    Brooke K. Higgins is a Branch Chief for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for reviewing both international and domestic drug CGMP cases and supporting regulatory and enforcement actions and provides training to FDA investigators and compliance officers within CDER and ORA. She has served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued performing domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a MS in Food Science, focusing on food microbiology, and a BS in Biology from Virginia Tech.

  • Panelist: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

    

    Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
    

    Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers.

Conference Summary from the Co-Chairs

Alte Stuttgarter Reithalle

• Co-Chair: Simone Biel, PhD, Senior Regulatory Consultant, Merck

  

  Simone Biel, PhD, Senior Regulatory Consultant, Merck
  

  Simone Biel is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing. She provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.

• Co-Chair: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

  

  Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc
  

  Darren has over 25 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems, he is an established SME for these processes, primarily focusing on Fedegari equipment. Darren is an established trainer and has delivered courses on industrial sterilization and autoclave operations across the world over the last 20years, Darren currently leads the Fedegari Technology Center in the US responsible for process consultancy focused on sterilization, decontamination, washing, associated aseptic processes and technical training.

Closing Remarks & Farewell

Alte Stuttgarter Reithalle

• Committee Member: Falk Klar, PhD, Parenteral Drug Association

  

  Falk Klar, PhD, Parenteral Drug Association
  

  Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.