This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
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.
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.
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