PDA EU00180 Manage Your Isolator for Aseptic Processing

Featured Trainers

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  Richard Denk

  SKAN AG

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  Richard Denk

  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.

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  Guido Herzberg

  SKAN Switzerland

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  Guido Herzberg

  SKAN Switzerland

  Guido Herzberg is a specialist for calibration and metrological qualification, he joined SKAN in 2000 as the first qualification engineer for aseptic or toxic isolator and shaped essentially the test procedures and equipment. In 2012 he founded the SKAN Academy to manage our growth and lead all new qualification engineers to sustainable quality. Guido Herzberg’s profession is the precision mechanic in the swiss watch industry, since 1987. For 10 years he worked as a specialist in development, manufacturing and installation of weather stations and meteorological instruments, e.g. part of the swiss federation project IMIS, a monitoring over the swiss alps for avalanche forecast.

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  Andrew D Hopkins, PGDip

  Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

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  Andrew D Hopkins, PGDip

  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.
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  Mathilde Jemelen

  Sales Engineer, SKAN AG

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  Mathilde Jemelen

  SKAN AG

  Mathilde has studied Process Engineering. After an initial work experience in the microelectronics industry she joined SKAN AG in 2020 as a Process Validation Engineer in the Process Validation Microbiology department. She performed cycle developments and microbiological qualifications of SKAN isolators all over the world as well as E-Beam Sterilization process validation. Today she supports the Sales Team as Sales Engineer.

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  Alex J. Kappani

  Product Management, SKAN AG

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  Alex J. Kappani

  SKAN AG

  Having worked for several years as Product Manager for glove intervention systems at SKAN, a high amount of experience on this subject is obtained by working with numerous global Pharmaceutical companies.
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  Harald Kiesel

  Strategic Product Manager, SKAN AG

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  Harald Kiesel

  SKAN AG

  Harald Kiesel, Dipl.-Ing, MBA is Strategic Product Manager at SKAN and responsible for the portfolio of sterile test isolators. In this position, he is mainly working for shaping the offering of SKAN isolators to meet market needs. He was able to gather experience in various roles within marketing and product management in the chemical and pharmaceutical industry.

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  Andreas Kindscher

  SKAN Germany

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  Andreas Kindscher

  SKAN Germany

  Andreas Kindscher is Product Line Specialist at SKAN and works in the area of Glove Management. Since his successful master's degree in mechatronics, he has worked in various areas, but mainly in his current area - Glove Management.  In this area he focuses on glove testing, glove materials and the correct use of gloves and forms the bridge between development, product and users.

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  Theresa Ladwig

  Sales Engineer, SKAN AG

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  Theresa Ladwig

  SKAN AG

  In 2007 Theresa Ladwig joined SKAN AG as a Project Engineer in the department Cycle Development and performed cycle development and microbiological qualifications all over the world. From 2013 to 2018 she was Head of Process Validation Microbiology. Today she supports the European Sales Team at the SKAN headquarters.

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  Max Mittelviefhaus

  Research Manager, SKAN AG

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  Max Mittelviefhaus

  SKAN AG

  Max Mittelviefhaus is a microbiologist (PhD) with a strong interest in the interface between biology and technology. In 2020, he joined SKAN AG as Research Manager in the Research and Strategic Business Development Department, where he is responsible for customer studies that SKAN offers through their SKANalytix services. In this role he is in frequent exchange with SKAN’s global clients, identifying their needs and concerns related to aseptic processing or decontamination technologies and translating these into appropriate scientific studies. SKANalytix thereby supports their clients with the necessary analytical data, to ensure quality and safety of aseptic operations in the pharmaceutical industry.

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  Tracy Moore

  Founder & CEO, TM Pharma Group Ltd

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  Tracy Moore

  TM Pharma Group Ltd

  In her capacity as an Expert GMDP Inspector, Tracy played a pivotal role as the primary MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain. Her expertise extended to providing guidance on the regulation of QP certification and overseeing the deployment of vaccines under Regulation 174. Tracy also contributed significantly to the pharmaceutical landscape by supporting the drafting of the GMP Annex 1 update, actively sharing insights on this matter at global events such as PIC/S. Among her notable achievements, Tracy served as the MHRA Data Integrity GXP lead and assumed the role of MHRA FMD GMP lead. Her involvement extended to being a key member of drafting groups for EU GMP Annex 16, Annex 21, Annex 1, Chapter 4, and Annex 11. Tracy represented MHRA on PIC/S subcommittees and took on leadership responsibilities by chairing working groups. Before joining the MHRA Inspectorate, Tracy amassed 22 years of experience in the pharmaceutical and Bio-Pharmaceutical industry. Her diverse roles encompassed QA, QP, and management positions in both commercial and R&D environments, covering a range of sterile and non-sterile product dosage forms. Tracy's responsibilities included conducting audits and overseeing Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers. With a decade of experience as a GMP Inspector and an additional three years as an Expert GMDP Inspector, Tracy has demonstrated a commitment to ensuring regulatory compliance and fostering collaboration with European and international regulatory authorities. Her multifaceted contributions extend to shaping and refining industry standards, making her a respected figure in the pharmaceutical regulatory landscape.

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  Martin Novak, MSc

  Technology Lead, SKAN AG

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  Martin Novak, MSc

  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.
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  Ruben Rizzo

  Sales Manager, SKAN Switzerland

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  Ruben Rizzo

  SKAN Switzerland

  Ruben Rizzo began his pharmaceutical career with an apprenticeship in chemical and pharmaceutical technology at Novartis, gaining a solid foundation in industry processes, particularly through his involvement in technical R&D. 

  Advancing his education, Ruben studied business and process management in Basel. Since 2014, Ruben has worked as an International Sales Manager, managing project sales in Switzerland and Southern Europe. His role at SKAN, marked by involvement in numerous successful projects for pharmaceutical isolators of various applications, has honed his deep technical insights and strategic business skills. This experience has been instrumental in driving significant market expansion and in cultivating robust client relationships across these territories.