Root Cause Analysis in the Pharmaceutical Landscape
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LevelAll Levels
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Total Enrolled131
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Duration36 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 Root Cause Analysis (RCA) in the pharmaceutical industry. In this comprehensive program, we delve into the significance of RCA and its pivotal role within the regulatory framework. Through interactive sessions, you’ll explore the fundamental concepts of RCA, learning to differentiate between symptoms and root causes, and understanding the importance of systemic issue identification.
We’ll equip you with the tools and techniques essential for conducting effective RCA, including Fishbone diagrams, 5 Whys technique, Fault Tree Analysis (FTA), Pareto Analysis, and Failure Mode and Effects Analysis (FMEA). Moreover, you’ll gain insights into regulatory considerations, compliance requirements, and the impact of RCA on regulatory inspections and audits. Furthermore, we’ll discuss best practices in RCA, such as establishing multidisciplinary teams, fostering a culture of continuous improvement, and implementing corrective and preventive actions (CAPA).
Finally, you’ll analyze real-world case studies to contextualize your learning and develop practical problem-solving skills. Join us on this journey to become proficient in Root Cause Analysis and drive quality excellence in the pharmaceutical industry.
Join us on this insightful journey into Root Cause Analysis to enhance your understanding of tools and techniques essential for conducting effective RCA, 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 RCA in the pharmaceutical industry.
- Key Concepts of Root Cause Analysis.
- Tools and Techniques for Root Cause Analysis.
- Regulatory Considerations in root cause analysis.
- Best Practices in Root Cause Analysis.
Course Curriculum
1. Root Cause Analysis in the Pharmaceutical Landscape
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1.1 Objectives
05:38 -
Quiz: Introduction to root cause analysis
2. Key Concepts
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2.1 Key Concepts
04:29 -
2.2 Key Concepts
03:55 -
Quiz: Key Concepts of Root Cause Analysis
3. Tools & Techniques
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3.1 Tools & Techniques
06:12 -
Quiz: Tools and Techniques for Root Cause Analysis
4. Regulatory Considerations
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4.1 Regulatory Considerations
02:56 -
Quiz: Regulatory Considerations in root cause analysis
5. Best Practices
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5.1 Best Practices
03:20 -
5.2 Best Practices
03:58 -
Quiz: Best Practices in Root Cause Analysis
6. Case Study
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6.1 Case Study
05:09 -
Quiz: Case Studies
7. Final Assessment
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Quiz
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Course Ratings & Reviews
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LevelAll Levels
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Total Enrolled131
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Duration36 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.