Course Description

This workshop begins with a review of the GMP requirements, GMP interpretations, FDA expectations and common GMP compliance problems associated with the product annual review program required by 211.180(e).

The workshop participants, working in small groups and using examples and data provided by the course instructor, will discuss the practical and effective methods for performing a product annual review. These include the selection, collection and organization of the critical information and data to perform the review; the development of specific instructions on “how to” perform the required trending for each section of the product annual review (e.g., analytical data, complaints, investigations and deviations, etc.); and “how to” prepare, and what information to include, in the product annual review report.

Each workshop participant will receive a written procedure with the necessary details on “what to” trend and “how to” trend, to ensure the performance of an effective and efficient product annual review. This written procedure will provide the critical information and details to guide the participant in the preparation of a company SOP on product annual review. Each participant will also receive an example of a product annual review report that outlines the necessary information to meet GMP requirements and FDA expectations.

Learning Objectives

To provide the course participant with the practical knowledge of the GMP and FDA requirements for a product annual review program; and the necessary practical skills to perform a product annual review that will meet FDA compliance requirements and ensure product quality.

Who Should Attend

This workshop is intended for the professionals who are responsible for supervising, performing, supporting, training or auditing the product annual review program.