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Potential and actual problems in production runs need to be treated at a foundational level to limit occurrences and reoccurrences. This is why GMP is the standard for manufacturing in the pharmaceutical and allied industries. Corrective Action and Preventive Action (CAPA) is one of the tools for maintaining the quality of the final product. This concept includes the identification of nonconformity or potential nonconformity in product batches and leads ultimately to the resolution of these issues at the ground level following detailed analysis and planning. This course introduces participants to CAPA and regulations that guide it (FDA 21 CFR 820.100.)
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: What is CAPA?
Lesson 2: Purpose of CAPA
Lesson 3: CAPA Requirements
Lesson 4: CAPA Procedures
Lesson 5: Objectives of CAPA
Lesson 6: Filling The CAPA Template Form