Preparing for FDA Pre-Approval Inspections

Preparing for FDA Pre-Approval Inspections

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This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection ac

GMP Inspections

GMP Inspections

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At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnolo