FDA CDER Draft Process Validation Guidance Rev.

FDA Center for Drugs (CDER), Center for Biologics (CBER) and Center for Vetinary Medicine released a a draft revision to its old 1987 Process Validation gudiance. This guidance is entitled: “Process Validation: General Principles and Practices”.

The revisions include significant flexibllity including use of process design information (even if not performed under cGMPs) to support process validation conclusions) and they define 2 basic stages for Process Validation: Stage 1 – Process Design and Stage 2 Process Qualifications. Stage 2 includes qualification of Utilities and Equipment and Performance Qualification.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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