Curriculum
- 2 Sections
- 23 Lessons
- 1 Day
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- Practical Applications and Continued Process Verification12
- 1.1Importance of CPV in lifecycle management
- 1.2Tools and techniques for monitoring process performance
- 1.3Data analytics in CPV: Practical implementation with examples
- 1.4Identifying root causes of deviations
- 1.5CAPA (Corrective and Preventive Action) implementation
- 1.6Interactive session: Real-life case studies of process deviations
- 1.7Key challenges and solutions in process validation
- 1.8Examples of successful validation in pharmaceutical companies
- 1.9Discussion: Aligning with global regulatory expectations
- 1.10Group exercise: Validation of a hypothetical product/process
- 1.11Action plan for implementing learnings at the workplace
- 1.12Q&A and open discussion
- Fundamentals of Process Validation Lifecycle Approach11
- 2.1Regulatory guidance: FDA, EMA, ICH Q8-Q10
- 2.2Stages of Process Validation Lifecycle: Process Design, Process Qualification, and Continued Process Verification
- 2.3Defining Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
- 2.4Quality by Design (QbD) principles
- 2.5Risk assessment tools: FMEA, Ishikawa diagrams
- 2.6Equipment qualification: IQ, OQ, PQ
- 2.7Challenges in facility, utility, and equipment qualification
- 2.8Case study: Successful implementation of Process Qualification
- 2.9Writing and reviewing validation protocols
- 2.10Practical insights into data collection and report preparation
- 2.11Hands-on group exercise: Creating a sample validation protocol
Tools and techniques for monitoring process performance
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