External GMP Audits for Pharma Companies

This GMP audit webinar will discuss the importance of external GMP audit, FDA requirements, best practices and steps for external audit execution, reporting, follow up and quality agreements between company and its suppliers/contractors.

Why Should You Attend:

Part of any Quality system program is the conducting of External GMP audits. The FDA and other agencies focus on the firms’ External audit programs for suppliers and contractors. An External audit program allows assessment of risk with contractors and suppliers that are used for drug product final release. The program should show how these suppliers and contractors are managed.

In this session, Mr. Torlini will provide the elements of setting up an External Audit program and the FDA expectations for External Auditing. He will also discuss the need to have R&D and Supply Chain involve with the program. It will also provide guidance on final Quality Agreement that should be in place to capture the responsibilities of both firms.