This book details how to develop and manage a Master Validation Plan to achieve compliance with FDA, GMP, and GLP requirements. The CD provides a template that can be customized for individual compani
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, F
Environmental Management System ISO 14001:2004 provides the information and practical know-how required to facilitate a smooth adoption and incorporation of the latest revisions and enhancements put f
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, inter
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online reso
