1:30 p.m. – 1:45 p.m.
Welcome and Opening Remarks from Workshop Co-Chairs
Tony M. Cundell, PhD, Consulting Microbiologist, Microbiological Consulting, LLC and
Michael J. Miller, PhD, President, Microbiology Consultants, LLC
1:45 p.m. – 2:15 p.m.
CDER & CBER Review Expectation
Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA
Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA
CDR James L. Kenney, DSc, Chief, LMIVTS, CBER,U.S. FDA
2:15 p.m. – 2:30 p.m.
Rapid Methods in Pharmaceutical Compounding
Haijing Hu, PhD, Senior Microbiologist, CDER, U.S. FDA
2:30 p.m. – 3:00 p.m.
Do the EU GMPs Require the Use of Rapid Microbiological Methods?
Andrew D. Hopkins, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
3:00 p.m. – 3:30 p.m.
Questions and Answers/Discussion