Pharmaceutical manufacturing is dependent upon facility design and maintenance, and many companies are faced with decisions about aging facilities. This session will provide an update on the PDA Task Force that is discussing strategies and risk management of Aging Facilities, and discuss some specific examples of unique challenges that manufacturers must deal with these facilities to maintain Good Manufacturing Practice as well as decision tools for balancing upgrade/replacement.
Moderator: Richard M. Johnson, President, PDA
Location: 1E15 & 1E16
1:45pm – 2:15pm
Presentation: PDA Aging Facility Task Force – Scope, Deliverables and Up-date
Speaker: Maik Jornitz, Chief Operating Officer, G-Con Manufacturing LLC
2:15pm – 2:45pm
Presentation: Aging Facilities: Are They Being Asked to Do Something More or Different Than Designed For?
Speaker: Christopher Smalley, PhD, Director, BioSterile Validation, Merck & Co., Inc.
2:45pm – 3:00pm