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This 12-hour accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries.

Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample management.

Preparing for inspections and auditing of the stability function will also be covered. Considerable attention will be given to risk management as applied to all aspects of Stability Operations.

The impact of several stability guidances (ICH, WHO, and FDA, among others) on Stability Operations will be discussed. The course concludes with a workshop for hands-on experience in risk management and auditing of Stability Operations programs.

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