Webinar

Management of an Effective CAPA

If your company is struggling with internal CAPAs, watch this webinar and learn how to implement a good CAPA program.

Informazioni sul contenuto

Why do so many companies struggle internally with their CAPA (corrective/preventive action) program? As with other regulations, US FDA Title 21, CFR Parts 211.160, 211.192, 810.100 have good definitions, but it’s up to companies to apply the requirements and then put their own approach and rationale together for a compliant CAPA program.
Here's the big question: how do we interpret the regulation, develop the procedure, and then get our internal teams to respond in a timely manner?
In this webinar, Tim Fischer explores the foundation and development of a good CAPA program, including what critical quality oversight and management review should entail.
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Informazioni sull'autore

Tim Fischer
Tim Fischer has worked with compliance in the Life Sciences for 30 years. He started his career at Abbott Labs in North Chicago, IL, in lab operations, manufacturing and technical support. He was able to build on his experience, spending several years as a Director of Compliance for three different contract manufacturing organizations. He then went on to work directly with compliance software platforms and now manages a consulting group focused on Quality 4.0 software initiatives, GMP quality systems/auditing and FDA/Supplier remediation.

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