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, …


Product and Process Validation Full Details
Understand Product and Process Validation.
  • Inform yourself about 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


Sample pages:

Combination products.

Validation testing.

Validation Planning.

Validation needs determination.



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