a2zConference

Sessions Speakers

Good Automated Manufacturing Practices (GAMP) in the Pharmaceutical Industry (Room 120)

05 Dec 20
9:00 AM - 10:00 AM

Tracks: Consumer Goods and Retail Trade

Whether developing the calibration program for the initial startup of a new facility, or redesigning an existing calibration program to minimize risk and increase efficiency, this seminar will provide an outline of the critical aspects that must be addressed. This material is based on the ISPE (International Society of Pharmaceutical Engineering) GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management. “Real World” examples of startup facilities that have implemented successful Calibration programs will be presented and analyzed. Attendees will learn how to redesign their current calibration programs to implement a paperless system that reduces compliance risk. Additionally, attendees will learn strategies on how to evaluate their instrumentation classification methodologies and other instrument specification strategies in order to reduce non-valued deviations. This is very interesting information.