Reference text on validation processes for manufacturing medical devices.

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edi

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical devi

At over 200 pages, this pocket book will bring you up to speed quickly on the requirements of process validation. It is divided into logical chapters that sets