PDA is delighted to announce we will be hosting two workshops to educate and help the industry with the August 2023 implementation of the new EU GMP Annex 1 revision. PDA has 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.
The intent of the workshops is to address the challenges and implications that have arisen with the implementation of the new EU GMP Annex 1. These workshops, scheduled for November and December, will focus on examining specific sections with critical changes and facilitating interactive sessions to provide attendees with a clear understanding of how to navigate and successfully meet the requirements of the revised EU GMP Annex 1. PDA has developed a standardized approach for workshop topics, ensuring that the information delivered to the industry remains consistent and relevant to the current regulatory landscape.
The workshops will be face-to-face, two days in length, and conducted globally (U.S. and EU). They 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 Ayers, ValSource, Inc. (Co-Chair)
- Tracy Moore, TM Pharma Group Ltd (Co-Chair)
- Angie Bragdon, Eli Lilly and Company
- Richard Denk, SKAN AG
- Chris Knutsen, Bristol-Myers Squibb
- Amanda McFarland, ValSource, Inc.
- Christopher Murdock, Bristol-Myers Squibb
- Don Singer, Ecolab Life Sciences
- Kim Sobien, ValSource, Inc.
- Oliver Stauffer, Packaging Technologies & Inspection LLC