4.60 (5 Ratings)

Corrective & Preventive Actions in the Pharmaceutical Industry

99 499

Description

Welcome to Pharmastate Academy’s comprehensive course on Corrective & Preventive Actions (CAPA) in the pharmaceutical industry. In this comprehensive program, we delve into the significance of CAPA in maintaining regulatory compliance and ensuring quality standards. Understand the dual nature of CAPA, encompassing corrective measures to rectify existing issues and preventive actions to forestall future deviations.

Learn the key objectives of CAPA, including ensuring compliance, managing risks, fostering continuous improvement, enhancing customer satisfaction, reducing costs, and bolstering reputation. Delve into the anatomy of nonconformities, dissecting their types, sources, and impact on quality and compliance.

Embark on a journey through the CAPA process, from identifying nonconformities to developing, implementing, and monitoring corrective and preventive actions. Explore powerful tools of root cause analysis, such as the Fishbone Diagram, 5 Whys technique, and Cause and Effect Analysis, to uncover underlying issues and formulate effective solutions.

Understand the integration of CAPA with Quality Management Systems (QMS), including its role in continual improvement and its relationship with other QMS processes like audits, document control, and training. Navigate regulatory requirements and standards related to CAPA, including ISO 9001 and FDA QSR.

Discover best practices for effective CAPA management, common pitfalls to avoid, and strategies for engaging employees in the CAPA process. Explore real-world case studies on contamination control, out-of-specification results, and regulatory compliance to contextualize CAPA principles and practices.

Join us on this insightful journey into Corrective & Preventive Actions to enhance your understanding of tools and techniques essential for conducting effective Corrective & Preventive Actions, and decision-making in the dynamic pharmaceutical landscape. Enroll now for a comprehensive learning experience that will empower you in the world of pharmaceutical quality.

What I will learn?

  • Importance of CAPA in Quality Management Systems.
  • Nonconformities
  • Corrective Action Process.
  • Integration of CAPA with Quality Management Systems.
  • Regulatory Requirements and Standards related to CAPA.
  • Implementation of an effective CAPA management.

Course Curriculum

1. Introduction

  • 1.1 Introduction
    02:55
  • Quiz: Introduction

2. Understanding Nonconformities

3. Corrective Action Process

4. Preventive Action Process

5. Integration of CAPA with QMS

6. CAPA Implementation

7. Case Study

8. Final Assessment

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Course Ratings & Reviews

4.6
Total 5 Ratings
5
3 Ratings
4
2 Ratings
3
0 Rating
2
0 Rating
1
0 Rating
NK
2 years ago
.
Good
PC
2 years ago
The course was nice, case studies and quizzes were helpful.
AG
2 years ago
Bery good
Payal Singh
2 years ago
This course has genuinely increased my regulatory knowledge and skills in terms using them in our workplace.
Thank you Pharma state Academy for such a wonderful course.. Highly appreciated👍😃
99 499

Material Includes

  • 7 Learning Videos
  • 8 Quizzes
  • Course Certificate

Target Audience

  • Pharma professionals from manufacturing.
  • QA, QC, and Regulatory Affairs.
  • Students pursuing D.Pharm, B.Pharm, M.Pharm, Ph.D, & Pharm D.

Course Ratings & Reviews

4.6
Total 5 Ratings
5
3 Ratings
4
2 Ratings
3
0 Ratings
2
0 Ratings
1
0 Ratings
NK
2 years ago
.
Good
PC
2 years ago
The course was nice, case studies and quizzes were helpful.
AG
2 years ago
Bery good
Payal Singh
2 years ago
This course has genuinely increased my regulatory knowledge and skills in terms using them in our workplace.
Thank you Pharma state Academy for such a wonderful course.. Highly appreciated👍😃

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