GXP2146 Corrective Action and Preventive Action (CAPA) Course

GXP2146 Corrective Action and Preventive Action (CAPA) Course

Description:

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.

 

Curriculum

 

Introduction

 

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

 

Glossary

 

Conclusion

 

Quiz

Author:

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

General info:

Duration:

1 hour

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

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

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Director of Operations

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GXP2146 Corrective Action and Preventive Action (CAPA) Course

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