This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutic

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

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri

Driven by such tools as big data, cognitive computing, new business models, and the internet of things, the overall demand for innovation is becoming more criti