Webinars>>Risk Management in GMP Facilities
Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues
Raw material related issues continue to be one of the most common findings during GMP inspections and most FDA warning letters to GMP facilities cite violations in raw material management. FDA’s GMP inspectors pay special attention to the way raw materials are sourced, handled, controlled, used, and accounted for at a given facility. There is mention of raw material management in GMP regulations for all kinds of FDA regulated products – drugs, biologics, medical devices, diagnostic kits, dietary supplements and veterinary products. The real challenge in raw material management lies in the fact that it is mostly based on the performance of independent vendors out of direct control of the GMP facility. Hence it is important for all GMP manufacturers to implement robust methods for raw material risk management.
Why should you attend:
This seminar is a must for GMP facilities or facilities trying to be GMP compliant irrespective of the kind of product manufactured: drug, biologic, diagnostic kit, medical device or dietary supplements. This seminar will help you understand the current requirements for raw material management with tips about practical implementation. We would discuss the FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies. Attendees will be able to use the training to evaluate existing programs and get tips about assuring compliance with FDA requirements. Impact on compliance with other regulatory requirements in other parts of the world will also be discussed.
Topics Covered in the Session:
Who will benefit:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: firstname.lastname@example.org