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Guidelines and Regulations

The FDA's Paul Motise showed this at a PDA meeting a few years ago. It's one of the best illustrations I've ever seen of the difference between Guidelines and Regulations in the GMP world.

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Validation Continuum

I've found this diagram to be helpful in understanding the overall Validation process and how the different efforts are related.

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Change Control template document

This is a template Change Control Assessment document we developed in cooperation with the O. M. Dean Company. Its purpose is to streamline the Change Control Assessment process to simplify Change Control in general.

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Sample Risk Assessment Document

We prepared a Risk Assessment document for a client in 2007, and decided to start out simple and see how it worked. It gave us a clear idea of what to validate first and what to validate later (if at all). It turned out to be very useful.