Product and Process Validation.

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Process ValidationFor detailed contents description >>>

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 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

Protocol Reporting

Implementation of the Audit programme to assure Validation effectiveness