Auditing Stability Programs: How to Ensure a Compliant Program

A significant number of 483’s and Warning Letters due to stability is proof that not all companies have an adequate program in place. Since the FDA GMPs provide only vague guidance as to the requirements for stability, much interpretation is left up to individual companies. Obviously a better understanding of FDA expectations is warranted. This 90-minute, accredited online training will cover all aspects of preparing for and conducting/hosting an audit of the medical product stability function.