PDA Annex 1 Workshop 2024

Registration Open

Welcoming

• 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 Remarks from Workshop Co-Chairs

• Co-Chair: 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.

• Co-Chair: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

  

  Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
  

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

P1: EU GMP Annex 1 Implementation – A Regulator’s Perspective

• 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.

Networking Coffee Break, Poster Session & Exhibition

P2: Quality Risk Management & Knowledge Management

• Moderator: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

  

  Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
  

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

• 11:10 – 11:30

  EU GMP Annex 1 and Quality Risk Management

  • 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].

• 11:30 – 11:50

  Knowledge Management in Pharmaceutical Manufacturing
• 11:50 – 12:05

  Q&A

  • Moderator: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

  • 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].

Breakout Session 1

Networking Lunch Break, Poster Session & Exhibition

P3: Cleanroom Design & Barrier System Integration

• 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.

• 13:50 – 14:10

  Cleanroom Design

  • Presenter: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

• 14:10 – 14:30

  Barrier Systems

  • Presenter: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

    

    Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
    

    With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.

• 14:30 – 14:45

  Q&A

  • 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: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

  • Panelist: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

    

    Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
    

    With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.

Breakout Session 2

Networking Coffee Break, Poster Session & Exhibition

P4: Decontamination & Material Transfer

• Moderator: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

  

  Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
  

  With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.

• 16:00 – 16:20

  Material Transfer

  • Presenter: Laura Brennan, European Technical Consulting Leader, Ecolab

    

    Laura Brennan, European Technical Consulting Leader, Ecolab
    

    Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is a European Technical Consulting Leader on Ecolab’s Life Sciences contamination control expert team. She has worked for Ecolab Life Sciences for several years and has held various roles within the technical consulting team. In her current role, she leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

• 16:20 – 16:40

  CCS on Indirect Product Contact Surfaces - Transfer and Assembly

  • Presenter: 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.

• 16:40 – 16:55

  Q&A

  • Moderator: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

    

    Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
    

    With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.

  • Panelist: Laura Brennan, European Technical Consulting Leader, Ecolab

    

    Laura Brennan, European Technical Consulting Leader, Ecolab
    

    Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is a European Technical Consulting Leader on Ecolab’s Life Sciences contamination control expert team. She has worked for Ecolab Life Sciences for several years and has held various roles within the technical consulting team. In her current role, she leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

  • Panelist: 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.

Breakout Session 3

Day 1 Wrap Up

• 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.

Networking Reception

Registration Open

P5: Personnel

• Moderator: 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.

• 08:20 – 08:40

  Training & Qualification

  • Presenter: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

    

    Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
    

    With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.

• 08:40 – 09:00

  Gowning & Personnel Monitoring

  • Presenter: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

• 09:00 – 09:15

  Q&A

  • Moderator: 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.

  • Panelist: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

    

    Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
    

    With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.

  • Panelist: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

Breakout Session 4

Networking Coffee Break, Poster Session & Exhibition

P6: Aseptic Processing & Pre-Use Post Sterilization Integrity Testing (PUPSIT)

• Moderator: Laura Brennan, European Technical Consulting Leader, Ecolab

  

  Laura Brennan, European Technical Consulting Leader, Ecolab
  

  Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is a European Technical Consulting Leader on Ecolab’s Life Sciences contamination control expert team. She has worked for Ecolab Life Sciences for several years and has held various roles within the technical consulting team. In her current role, she leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

• 10:30 – 10:50

  Aseptic Processing 1

  • 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.

• 10:50 – 11:10

  Aseptic Processing 2

  • Presenter: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

• 11:10 – 11:25

  Q&A

  • Moderator: Laura Brennan, European Technical Consulting Leader, Ecolab

    

    Laura Brennan, European Technical Consulting Leader, Ecolab
    

    Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is a European Technical Consulting Leader on Ecolab’s Life Sciences contamination control expert team. She has worked for Ecolab Life Sciences for several years and has held various roles within the technical consulting team. In her current role, she leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

  • 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: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

Breakout Session 5

Networking Lunch Break, Poster Session & Exhibition

P7: EM & Airflow Visualization

• Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

  

  Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
  

  Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

• 13:10 – 13:30

  Environmental and Process Monitoring

  • 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.

• 13:30 – 13:50

  Airflow Visualization

  • Presenter: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

• 13:50 – 14:10

  Aseptic Process Simulation

  • Presenter: Maria Ginnelly

    

    Maria Ginnelly
    

• 14:10 – 14:25

  Q&A

  • Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

    

    Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
    

    Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

  • Panelist: 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.

  • Panelist: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

  • Panelist: Maria Ginnelly

    

    Maria Ginnelly
    

Breakout Session 6

Networking Coffee Break, Poster Session & Exhibition

Passport Raffle

P8: Contamination Control Strategy

• 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.

• 15:45 – 16:05

  Contamination Control Strategy

  • 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].

• 16:05 – 16:45

  Plenary 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: 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].

  • Regulatory Panelist: Thomas Vestergaard Pedersen

    

    Thomas Vestergaard Pedersen
    

  • Regulatory Panelist: Aedin Hogan

    

    Aedin Hogan
    

Day 2 Report Out & Closing Remarks from the Workshop Co-Chairs

• Co-Chair: 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.

• Co-Chair: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

  

  Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
  

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

Closing Remarks & Farewell

• 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.