Regulatory Compliance for Biologics and Drugs

A vital reference book for professionals in the industry as well as sponsors of human clinical trials and clinical research organizations, Regulatory Compliance for Biologics and Drugs features: examples of forms on how to write specific process deviations (that the FDA find acceptable), how to implement an effective document change control system, and an effective strategy on investigating a sterility test failure. The book covers specific topics related to regulatory compliance with relevant background information in a clear, concise, and authoritative manner. Situations that are complex and highly interpretive are explained using real experiences. Features also include sections on how virtual companies can deal with contract manufacturing and testing. See more