Back by popular demand, the 2023 PDA Annex 1 Workshop (Raleigh) is designed to educate and help the industry implement the new Annex 1 revision. PDA has been, and continues to be, committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole.
The Workshop will highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1, in order to address the regulatory expectations. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry.
This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers’ challenges and best practices.
SUBJECT MATTER EXPERTS
- Frederic B. Ayers, Research Scientist, Eli Lilly and Company and Workshop Co-Chair
- Tracy Moore, Director, TM Pharma Group Ltdand Workshop Co-Chair
- Bianca Bohrer, Managing Director, PSM GmbH
- Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company
- Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
- Irving Ford, MSc, VP of Quality, Adaptimmune
- Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
- Thorsten Haefner, MBA, Vice President of Business Development, PSM GmbH
- Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.
- Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK
- Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC
- James Wamsley, Consultant, ValSource, Inc.