# 605: Process Validation, Tuesday, January 11, 2010 http://www.acteva.com/booking.cfm?bevaid=182415
The major factors that contribute to GMP-related recalls are post-production problems. The primary reasons for those problems include poorly characterized product design and manufacturing processes, inadequate or poorly planned and executed design and process validations, and lack of adequate production controls. As a result, customers are exposed to unnecessary hazards, product quality is inconsistent, and businesses are adversely affected. This workshop will cover the elements of process validation and present industry "best practices". Topics covered in the workshop will include design verification and validation, process validation planning, and installation, operation and performance qualification, and process validation. In addition, applicable FDA's Quality System regulations will be reviewed for participants working in medical devices and in vitro diagnostics. The class format includes interactive group exercises designed to illustrate th e various aspects of a validation program. Handouts describing the contents of these applications will also be provided. Instructor: Dr. Wayne Schrier
