Panel Discussion on Qualification, Validation, and Compliance in Pharma Microbiology
In Partnership with EPR
Overview
The panel discussion features Mark Schweitzer, a microbiology expert committee chair, and panelists Edward Tidswell, James Drinkwater, Richard Denk, and Marie Jorna. They discuss Annex One, contamination control strategies, data integrity, and technology in pharma microbiology. The conversation covers challenges in implementing new requirements, the importance of team effort, and the impact of new technologies on data integrity. The panel also addresses the need for standards to capture new technologies and engage with stakeholders, as well as the challenges with slow technology adoption in standard setting. Overall, the discussion emphasizes the criticality of compliance, the importance of risk assessment, and the need for advanced techniques and tools in pharma microbiology.
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Key Learnings from the Panel Discussion:
- GMP Annex 1 and Risk-Based Approaches
- Data Integrity and New Technologies
- Developing Contamination Control Strategies
Panelists
Mark Schweitzer
Moderator, USD Microbiology Expert Committee Chair
Various pharma companies including Novartis, AbbVie, Pfizer
Over the past 38+ years, Dr. Schweitzer has held senior positions in analytical development, quality control and quality, the most recent of which was as the Global Head of Analytical Science & Technology and Scientific Initiatives in Novartis Quality.
Edward Tidswell
Panelist
Merck BioReliance Services
Dr. Tidswell is Executive Director within the Microbiological Quality and Sterility Assurance organization of Merck with ownership over sterility assurance and microbiology quality and compliance issues across all sterile and non-sterile products and manufacturing.
James Drinkwater
Panelist
Franz Ziel GmbH
James Drinkwater is the Head of GMP compliance at FranzZiel Germany supporting international Pharmaceutical manufacturing/ Filling projects from a UK base.
Richard Denk
Panelist
SKAN
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 Annex 1 - ISPE Commenting Team and current co-chair of the ISPE European Affiliate Council, chair of the Containment CoP and Future Robotics of the ISPE DACH.
Marie Jorna
Panelist
MSD
Mrs Jorna leads the Data Integrity program for MSD Animal Health Manufaturing division to ensure that GMP data are meeting the ALCOA principles. She is also involved in digitalization projets to standardize and improve processes as well as ensuring Data Integrity.