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Why Process Validation is Reliant on a Detailed Design Review of the Product [Video]
Process validation is reliant upon a detailed review of the design of the product....
Critical Process Parameters – Process Validation
The first phase of the process design entails developing a detailed knowledge and understanding...
The 3 Phases of Process Validation to Ensure Quality, Safety & Efficacy [Video]
According to the FDA’s new guidance on process validation which was published in 2011....
Traditional Vs Modern Approach to Process Validation [Video]
Prior to 2011, Process Validation (PV) was defined as Documented evidence that the process,...
How to Decide What Processes Need to be Validated [Video]
Each process should have specifications describing both the process parameters and the desired product....
6 Key Areas the FDA Audit for Process Validation
In general, validation is confirmation by examination and provision of objective evidence that the...
Typical Contents of a Validation Master Plan (VMP)
A Validation Master Plan, also referred to as “VMP”, outlines the principles involved in...