Industry Trends and Regulatory Expectations

Date: Tuesday, March 18
10:45 am – 12:15 pm

Location: 1E15 & 1E16

Speakers: Hal Baseman, Michael Long, PhD, Richard L. Friedman

Description:
Sterile biopharmaceutical product manufacturing remains a dynamic and challenging segment of our industry. This session will bring regulators and industry together to discuss expectations and explore trends focused on the use of technology, risk based decision making, process capability, and quality systems needed to achieve the objective of manufacturing excellence.
Moderator: Hal Baseman, Chief Operating Officer, ValSource, LLC

Session schedule:
10:45am – 11:15 am
Presentation: Regulatory Expectations – Pharmaceutical Manufacturing
Speaker: Richard L. Friedman, Associate Director, Office of Compliance, CDER, FDA

11:15am – 11:45am
Presentation: Driving Manufacturing Excellence
Speaker: Michael Long, PhD, Director & Principal Consultant, ConcordiaValSource, LLC

11:45am – 12:15pm

Q&A/Discussion