Session: B2: Supplier Oversight

Live Q&A (B2)

Tuesday, September 28, 2021

14:23 – 15:00 EDT

The globalization of pharmaceutical manufacturing of API and FDF has been accompanied by explosive globalization of the supply chains. The number of entities performing distribution, packaging, transportation, warehousing, contract manufacturing/testing, material supply, and other functions, has added greater complexity to ensuring safety and quality of drug products. This session will focus on managing lifecycle risks introduced by global supply entities, as illustrated by real world case studies. The discussion will also reference multiple relevant ICH guidances.

Moderator(s)

KQ

Keduo Qian, PhD

Chemist, CDER
U.S. FDA
Bethesda, Maryland, United States

Panelist(s)

Mirko Gabriele, PhD

Senior Director, Global Sterile Strategy Technology and Innovation
ThermoFisher Scientific
Ferentino, Lazio, Italy
John M. McShane, MBA

Vice President, BIologics
Lachman Consultant Services, Inc.
San Francisco, California, United States

Regulatory Panelist(s)

CDR Tara Gooen Bizjak, MBS

Director, Manufacturing Quality Guidance and Policy Staff, CDER
U.S. FDA
Silver Spring, Maryland, United States