More than 650 typical questions related to audits and inspections.Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.For auditors and manufacturers of drugs and APIs.NEW ++ NEW ++ NEW
A Drugmaker‘s GuideHere’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.NEW ++ NEW ++ NEW
Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Here you'll find a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.