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A guidebook to FDA compliance, this text lists the necessary steps for meeting compliance requirements during the drug development process. Presenting comprehensive approaches for validating analytical methods for pharmaceutical applications, it covers important compliance and quality systems used in the FDA-regulated industries related to medical devices, pharmaceuticals, and biologics. The book includes topics such as validating analytical methods for pharmaceutical applications, stability testing, computer validation, vendor qualification, internal audit programs, and strategic planning for compliance and regulatory defensiveness.
List of contents
Regulatory submissions, Patricia Fritz and Anisa Dhalla; compliance requirements during the drug development process, Martin D. Hynes; validation - a new perspective, James Agalloco; validating analytical methods for pharmaceutical applications - a comprehensive approach, Paul A. Winslow and Richard F. Meyer; the stability testing programme, Maria Geigel; computer validation - a compliance focus, Timothy Horgan and Timothy Carey; compliance issues associated with cleaning in the pharmaceutical industry, William E. Hall; the batch record - a blueprint for quality and compliance, John Fugate; change management - a far reaching, comprehensive and integrated system, Susan Freeman; the vendor qualification programme, Eizabeth M. Troll and Karen L. Hughes; handling laboratory and manufacturing deviations, Robert B. Kirsch; the internal audit programme - a quality assessment, Graham Bunn; pre-approval inspections - the critical compliance path to success, Martin D. Hynes; international compliance issues and trends, Alan G. Minsk; strategic planning for compliance and regulatory defensiveness, Ron Johnson; unique and unprecedented compliance challenges in the biologics area, Anne Hoppe and Curtiss Scribner; the impact of total quality performance on compliance, Carmen Medina, Judith Beach, Valerie Palumbo and Douglas B. Poucher.
About the author
Carmen Medina
