Product and Process Validation.
Information and training presentation.
… IQ, OQ, PQ, Design Qualification, Approach to Cleaning Validation, Validation Gap Analysis, Validation Master Plan, Validation versus Verification, Protocol Reporting, Auditing for Validation compliance, Equipment, Facility, Material Validations, …
Understand Product and Process Validation.
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- 590 pages of information, provided in a visual, easy to understand format.
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- Introduction to Product and Process Validation
- Determination of the need for Validation (versus Verification)
- Integration of Risk assessment into Validation planning
- Performing a Validation Gap Analysis
- Implementing the Validation Programme (IQ, OQ, PQ)
- Creating and implementing the Validation Master Plan (VMP)
- Requirements for effective and compliant Validation during the Design process
- Product and process Software Validation
- Cleaning Validation
- Cleaning Process Sampling and Test Methods
- Documentation Control and Management for ensuring Validation compliance
- Equipment, Component, Material and Facility Validation
- Implementation of a re-Validation programme
- Protocol Reporting
- Implementation of the audit programme to assure Validation effectiveness