PDA New England Chapter Event: Spring Dinner Meeting

Please join us for this exciting event! Our expert guest speakers will be presenting on Phase-Appropriate Application of GMPs: Expert Perspectives with Case Studies. You will learn tips for conducting world class investigations and how to implement phase appropriate GMP quality systems.

This event will take place at the Four Points by Sheraton, Norwood, MA

*At this time we are accepting registration at the door only

Presentation Abstracts

James Blackwell: World class investigations are within reach of every organization and this talk will show you how. The business and compliance importance, and challenges of achieving excellence will be reviewed. Lessons learned apply to both clinical stage companies and multinational corporations. Insights will be gained into the most common mistakes and how to avoid them. Some of the most memorable investigations in Dr. Blackwell’s career and lessons learned will be shared along with a peek into the future of investigations.

Amnon Eylath : Amnon will present current industry thoughts on how to best implement phase appropriate GMP quality systems, practices and procedures, in alignment with international Health Authority expectations. Key concepts will be drawn from PDA Technical Report TR56 (Application of Phase Appropriate Quality Systems and GMP to the development of Biological API). Topics covered will be: The drivers and rationale for implementing Phase Appropriate GMP ; The partnership between PDA, Industry and FDA in developing and updating TR 56; The application of science and compliance-based thinking; Phase Appropriate Quality Systems and GMPs, as implementation of best practices for product development quality; The interaction and synergy between GMP and CMC • Phase Appropriate CMC and the Specification development timeline; What's next? Expanding TR 56 to include ATMPs.