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This Medical device training will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with the new standards.

Learn the new GMP regulation 21 CFR 212, what are the compliance requirements for PET drug manufacturers, how to establish a quality system to ensure cGMP compliance.

This Part 11 Inspection training will answer all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements.