Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Carmen Medina

• 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.

"…The book captures the reader's attention from the first chapter and paves a lively way for prosecution of further independent studies….One of those invaluable books which any reader will want to have beside him as he comes into face with questions of FDA's changing and regulatory demands…."…the strategies and programs offered in this book can significantly decrease a company's compliance vulnerability and regulatory liability and increase its overall quality."-Current Engineering Practice"…gives manufacturers sound, practical advise on inspection readiness and overall compliance."-E-Streams