Corrective & Preventive Actions in the Pharmaceutical Industry
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LevelAll Levels
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Total Enrolled58
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Duration29 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
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
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1.1 Introduction
02:55 -
Quiz: Introduction
2. Understanding Nonconformities
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2.1 Understanding Nonconformities
03:34 -
Quiz: Understanding Nonconformities
3. Corrective Action Process
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3.1 Corrective Action Process
03:41 -
3.2 Corrective Action Process
02:04 -
Quiz: Corrective Action Process
4. Preventive Action Process
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4.1 Preventive Action Process
02:03 -
4.2 Preventive Action Process
01:56 -
Quiz: Preventive Action Process
5. Integration of CAPA with QMS
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5.1 Integration of CAPA with QMS
03:54 -
Quiz: Integration of CAPA with QMS
6. CAPA Implementation
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6.1 CAPA Implementation
02:40 -
6.2 CAPA Implementation
02:30 -
Quiz: CAPA Implementation
7. Case Study
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7.1 Case Study
03:39 -
Quiz: Case Study
8. Final Assessment
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Quiz: Final
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Course Ratings & Reviews
Thank you Pharma state Academy for such a wonderful course.. Highly appreciated👍😃
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LevelAll Levels
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Total Enrolled58
-
Duration29 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
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.
Tags
Educators
Course Ratings & Reviews
Thank you Pharma state Academy for such a wonderful course.. Highly appreciated👍😃