Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar

This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA inspectors as major areas of concern in FDA regulated pharma laboratories. The topics addressed will include FDA requirements for OOS investigations, equipment program, pharmaceutical and biologics stability programs, method validation and handling regulatory inspections. During the discussion of each of the areas listed below, the workshop participants will work through a series of related FDA 483s to fully understand FDA expectations and the errors which lead to the 483s.

• QC chemists, supervisors and managers
• R&D chemists, supervisors and managers
• QA managers and personnel
• Regulatory affairs personnel