PDA Delaware Valley Chapter: EU GMP ANNEX 1

The Delaware Valley Chapter is pleased to invite you to an in-person event on Annex 1.

Please Join us for a Dinner Meeting at the Desmond Hotel and Convention Center in Malvern, PA for a panel discussion surrounding the review and implementation of the new EU GMP Annex 1, Manufacture of Sterile Medicinal Products into operations.

This meeting will include panel participants from GMP organizations who are currently implementing strategies to meet the requirements in the newly released guidance documents. This moderated session will include the ability of the audience to ask the panelists pertinent questions as to how they and their organization are addressing each phase of the released guidance.

The basis of the meeting is for GMP organizations to learn from other GMP organizations on how they may be implementing the needed and required attributes to comply with the guidance.

Panelists/Moderator:

• Pat Bailey, Merck & Company
• Angel Salaman , Janssen Pharmaceuticals
• Mitch Garber, 2seventybio
• Art Vellutato, Jr.,Veltek Associates, Inc. – Moderator