International regulatory agencies like US FDA and EMEA have restructured the concept of ‘process validation’ into three stages namely ‘Process Design’, ‘Process Qualification’ and ‘Continued Process Verification’ during routine manufacturing. Thorough Process knowledge and understanding is the basis for establishing an approach to control the manufacturing process that results in products with desired quality attributes. Understanding the source of variation, detecting the presence & degree of variation and their impact on process as well as ultimately on product quality are the key requirements. This approach is expected to bring in an element of robustness into the manufacturing process and quality system.
This webinar will provide an overview of concepts and strategies for execution of the validation program based on risk approach in line with current expectation of international regulatory agencies.
Areas Covered in the Session :
- Stages of process validation
- Importance of thorough process knowledge
- Quality life cycle concept
- Process design
- Process performance qualification
- Differences between US FDA and other guidelines
- Application of risk approach to process validation
- Strategies to implement Continuous Process Verification stage
- Protocols and report content
Who Should Attend:
- Research and Development Departments
- Engineering Departments
- Quality Departments
- Manufacturing Departments
- Operations Departments
- Production Departments
- Document Control Professionals
- Device Development Teams
- Quality Auditors
- Personnel involved in Verification and Validation planning
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