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
