Training Course A: Science and Risk Based GMP Compliance in Drug Manufacture

This course of five training sessions will review the background and guidance dealing with science and risk based GMP compliance and the various approaches suggested by FDA, ICH, and ASTM to mitigate risk and ensure proper compliance is achieved. This course will focus on first discussing the FDA Initiative of August 2002 titled “Pharmaceutical CGMP for the 21st century – A Risk-based Approach” and its implication. Attendees will also review subsequent progress reports issued by the FDA regarding suggested approaches to mitigate risk. Additionally attendees will review what is meant by Product Life Cycle and Manufacturing Life Cycle as well as review the jargon associated with the subject. Finally, they will discuss Risk and Risk Levels and how to implement ICH Q9 guidance.

Once attendees have established the basic principles, they will review the relevant guidance and approaches to mitigate risk in drug manufacturing as outlined in FDA progress reports associated with the August 2002 Initiative. These will include a review of ICH Q8 and the concept of quality by design, the use of Corrective Action and Preventive Action (CAPA), and the concept Process Analytical Technology as well as the use of automation to mitgate risk in drug manufacture.