PDA - New England Chapter - Dinner Meeting & Networking Event


PDA - New England Chapter - Dinner Meeting & Networking Event
Evaluating Contract Manufacturing and Risk Analysis in Research Model Production

Wednesday, March 9, 2016
5:30 to 9:00 pm

Hilton Boston Woburn
2 Forbes Road
Woburn, MA 01801

Topic Overview: The March Dinner Meeting will focus on two topics:

Evaluating Contract Manufacturing for Biotech and Cell and Gene Therapy:
This presentation gives a compliance and experience-based overview of the key activities that a sponsor should take when assisting a CMO for the manufacturing of biotech products. In addition, the special requirements for Gene and Cell therapy are discussed. Key points covered will be the principles of using risk assessments, as recommended by ICH Guidance; Leading indicators and risk indicators that are valuable in reducing the risks of selecting an unsuitable CMO; Due diligence activities and recommendations for the oversight of quality and operational risks, once the CMO has been selected and is in operation.

Risk Analysis of Non-Conformances in Research Model Production:
This presentation will outline the assessment of the criticality of quality non-conformances and how they are addressed. It will describe the process by which risk is assessed to non-conformances and how they are addressed in a unique production environment and how that compares with their GxP analogs.

Speakers for the evening will be:
Amnon Eylath, the VP of Quality Operations, Quality Management Systems and GxP compliance at Histogenics Corp.
Andre Merza, Senior Quality Systems Specialist for Charles River Laboratories in North America.

For more information on the New England Chapter of PDA, or to register for an event, please visit their website