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GXP2146 Corrective Action and Preventive Action (CAPA) Course

GXP2146 Corrective Action and Preventive Action (CAPA) Course


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?


  • Differences and Relationship Between Corrective and Preventive Action


Lesson 2: Purpose of CAPA


Lesson 3: CAPA Requirements


Lesson 4: CAPA Procedures


  • Identification of the Nonconformity
  • Evaluation of the Nonconformity
  • Investigation and Root Cause Analysis
  • Action Plans
  • Implementation of Action Plan
  • Verification
  • Closure


Lesson 5: Objectives of CAPA


Lesson 6: Filling The CAPA Template Form








GXP2146 Corrective Action and Preventive Action (CAPA) Course
Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job

$90.00 $150

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This course provided a healthy background for the concept of CAPA which is necessary for ensuring consistently homogenous results from the manufacturing process. We can already see our employees applying the knowledge obtained productively in the manufacturing process.

Michelle V


Director of Operations

$90.00 $150

3 days left at this price!

Buy now
GXP2146 Corrective Action and Preventive Action (CAPA) Course

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