Keynote: Pharmaceutical Quality: Basic Expectations Ashley B. Boam, MSBE | Watch Recording |
A Review Perspective on the Pharmaceutical Quality System Robert Iser, M.S. | Slides: Download ZIP at top pf page Watch Recording |
Production and Process Controls: Overview of CGMP Regulations and Regulatory Expectations Vibhakar Shah, Ph.D. Production and Process Controls: Regulatory Expectations for Microbiological Quality of Pharmaceuticals Vinayak B. Pawar, Ph.D. | Slides: Download ZIP at top pf page Watch Recording |
Laboratory Controls & Microbiology Testing – CGMP Regulations & Guidance John W. Metcalfe, Ph.D. Frank W. Perrella, Ph.D. | Slides: Download ZIP at top pf page Watch Recording |
Facilities & Equipment Regina T. Brown | Slides: Download ZIP at top pf page Watch Recording |
Q&A: Panel Discussion Day One Speakers | Watch Recording |
Materials System: Basic CGMP Requirements Alicia Mozzachio, R.Ph., MPH Minerva Hughes, Ph.D., R.A.C. | Slides: Download ZIP at top pf page Watch Recording |
Packaging & Labeling Allison A. Aldridge, Ph.D. Karen Takahashi, M.S. | Slides: Download ZIP at top pf page Watch Recording |
What to Expect During a FDA Drug Manufacturing Inspection Denise DiGuilio | Slides: Download ZIP at top pf page Watch Recording |
Case Studies Tamara Felton Clark | Slides: Download ZIP at top pf page Watch Recording |
Q&A: Panel Discussion Day Two Speakers | Watch Recording |