GMP Consultancy, GMP Audit and FDA Training for Roche Diagnostics Mannheim, Germany

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For Roche Diagnostics, PCS has provided a number of services which included FDA training on; Introduction to the FDA, The FDA’s mandate and objectives, Pre-approval inspections: purpose, scope and focus, Preparing for the FDA, Managing the FDA inspection, Interacting with the FDA investigator, The “ 483” document, The follow-up process and the review of some current hot topics associated with sterile product manufacture. Furthermore, PCS reviewed GMP qualification documentation for production equipment and assisted with the deviation system of Roche.

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