Program Overview
This training program provides an in-depth understanding of the Process Validation Lifecycle Approach, including Process Design, Qualification, and Continued Process Verification. It combines regulatory guidance, risk management techniques, and real-life case studies to equip participants with the knowledge and skills required to ensure robust validation practices. With practical insights, hands-on group activities, and actionable tools, participants will learn to address challenges such as process deviations, equipment qualification, and continuous monitoring to align with global regulatory expectations.
Features
- Comprehend the complete Process Validation Lifecycle and its regulatory framework.
- Apply Quality by Design (QbD) principles and risk management tools to validation processes.
- Develop and evaluate validation protocols, reports, and documentation.
- Implement Continuous Process Verification (CPV) and address deviations using CAPA strategies.
Target audiences
- Pharmaceutical manufacturing professionals
- Quality Assurance (QA) and Quality Control (QC) specialists
- Process engineers
- Validation scientists
Curriculum
- 2 Sections
- 23 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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
Instructor
