9780471738404 - Establishing A CGMP Laboratory Audit System: A Practical Guide de Bliesner, David M. (7 resultados)

Hardcover. Condición: Near Fine. 0471738409. Includes UNUSED, sealed CD-ROM. A near fine unread Pictorial board hardcover, from closed pharmaceutical company library. Lending record shows this book has never been borrowed. Index, illustrated with tables. Pharmaceutical laboratories must demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. This book provides laboratory supervisors with an audit system that they can rely on to ensure their facility remains compliant. Paper clip mark on front endpapers, otherwise contents as new, clean, tight and bright. Book.

Hardcover. Condición: Near Fine. 0471738409. Includes UNUSED, sealed CD-ROM. A near fine unread Pictorial board hardcover, from closed pharmaceutical company library. Lending record shows this book has never been borrowed. Index, illustrated with tables. Pharmaceutical laboratories must demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. This book provides laboratory supervisors with an audit system that they can rely on to ensure their facility remains compliant. Paper clip mark on front endpapers, otherwise contents as new, clean, tight and bright. Book.

hardcover. Condición: New. In shrink wrap. Looks like an interesting title!

Condición: New. DAVID M. BLIESNER, PhD, is the founder and President of Delphi Analytical Services, Inc., in Indian Rocks Beach, Florida, a company offering training, training technology, and compliance products and services to the pharmaceutical, biopharmaceutical, medica.

Hardcover. Condición: Brand New. hardback/cd-rom edition. 277 pages. 9.25x6.25x0.75 inches. In Stock.

Hardback. Condición: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.

Hardcover. Condición: new. Hardcover. The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory. Establishing a CGMP Laboratory Audit System: A Practical Guide guides the reader through establishing a Current Good Manufacturing Practices laboratory audit system using detailed flowcharts, checklists, and descriptions of the process. Templates and checklists on a CD-ROM provide for easy use and modification in the laboratory. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.