Product and Process Validation.
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Summary of contents:
Determining 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 Process Sampling and Test Methods
Documentation Control and Management for ensuring Validation compliance
Regulation of Combination Products (US FDA)
Cleanroom Classification and Control
Validating and Monitoring the Cleanroom
Equipment, Component, Material and Facility Validation
Implementation of a re-Validation programme
Implementation of the Audit programme to assure Validation effectiveness