Change Management Systems in the Pharmaceutical Industry
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LevelAll Levels
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Total Enrolled21
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Duration39 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 Change management Systems in the Pharmaceutical Industry. This comprehensive program covers the stages of a Change Management System, including change initiation, request process, impact assessment, risk analysis, approval, implementation, validation, review, and documentation.
We’ll equip you with Practical tools and techniques for Change Control, such as change control forms, risk assessment matrices, change control meetings, and electronic change management systems. Moreover, you’ll gain insights into Change Management Models and Frameworks such as Kotter’s 8-Step Change Model, ADKAR Model, Lewin’s Change Management Model, and Prosci’s Change Management Process. Additionally, regulatory requirements, international standards, and the importance of compliance in pharmaceutical Change Management will be discussed, including FDA regulations, ICH Q10, ISO 9001, and more. 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 the Change Management System to enhance your understanding of tools and techniques essential for conducting effective Change Management System, 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 Change Management in Pharmaceuticals.
- Concepts of Change management Systems.
- Stages of Change Management System.
- Types of Changes in Pharmaceuticals.
- Change Management Models and Frameworks.
- Regulatory Requirements for Change Management.
Course Curriculum
1. Change Management Systems in the Pharmaceutical Industry
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1.1 Objectives
04:01 -
Quiz: Introduction
2. Stages of Change Management
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2.1 Stages of Change Management
05:51 -
2.2 Stages of Change Management
03:42 -
Quiz: Stages of a Change Management System
3. Types of Changes in Pharmaceuticals
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3.1 Types of Changes in Pharmaceuticals
04:55 -
Quiz: Types of Changes in Pharmaceuticals
4. Models & Frameworks
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4.1 Models & Frameworks
05:43 -
Quiz: Change Management Models and Frameworks
5. Regulatory Requirements
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5.1 Regulatory Requirements
04:32 -
Quiz: Regulatory Requirements for Change Management
6. Change Control Tools &Techniques
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6.1 Change Control Tools &Techniques
07:01 -
Quiz: Change Control Tools and Techniques
7. Case Studies
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7.1 Case Studies
03:16 -
Quiz: Case Studies
8. 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 Enrolled21
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Duration39 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
Material Includes
- 8 Learning Videos
- 9 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.