Any departure from an approved instruction or established standard used in the manufacturing process, including data or results outside of the expected range, is considered a deviation and must be investigated and evaluated for impact to product quality. Other terms are used for deviations in regulations and guidance, including “non-conformances” and “discrepancies”. Whichever terminology is used, deviations are a normal part of any manufacturing process, but how they are handled is a matter defined in the law as per 21CFR211.100, 211.111, and 211.160 and various other EU GMP guidelines. Participants in this course will use real world examples to learn the process of identifying, documenting, and evaluating deviations.
Note: Corrective and Preventive Actions (CAPA) is addressed in a separate course.
By the end of the course, participants will be able to:
- Define deviation (or non-conformance) and know when and how to identify when they occur.
- Use best practices for documenting deviation occurrence in a clear, concise, and timely manner.
- Discuss the importance of investigating and justifying deviations.
- Evaluate deviations based upon their impact and assign appropriate investigation activities commensurate with the level of risk.
- Monitor for and identify deviation trends and implement appropriate corrective actions.
- Learn when and how to apply deviation management throughout the product lifecycle; with varying levels of formality applied based upon scientific and risk-based knowledge.
Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management and service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients.
Cost: Half-day class
Location: Location and driving directions will be emailed separately upon registration.