Anbieter: PBShop.store UK, Fairford, GLOS, Vereinigtes Königreich
EUR 111,14
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In den WarenkorbUNK. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
EUR 144,99
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In den WarenkorbZustand: New. pp. viii + 291 Illus.
Anbieter: PBShop.store UK, Fairford, GLOS, Vereinigtes Königreich
EUR 146,41
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In den WarenkorbHRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 155,66
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In den WarenkorbHardcover. Zustand: Brand New. hardback/cd-rom edition. 291 pages. 9.50x6.25x0.75 inches. In Stock.
Anbieter: Majestic Books, Hounslow, Vereinigtes Königreich
EUR 170,72
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In den WarenkorbZustand: New.
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In den WarenkorbZustand: New. Validating Chromatographic Methods: A Practical Guide intends to bring order to the potentially chaotic process of methods validation. It provides the novice with enough practical information and tools to keep from having to reinvent the wheel by having to develop their own systems to attach methods validation from scratch. Num Pages: 304 pages, Illustrations. BIC Classification: PNFC. Category: (P) Professional & Vocational. Dimension: 241 x 164 x 21. Weight in Grams: 596. . 2006. Hardcover. . . . . Books ship from the US and Ireland.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 182,91
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In den WarenkorbHardcover. Zustand: Brand New. hardback/cd-rom edition. 277 pages. 9.25x6.25x0.75 inches. In Stock.
EUR 141,74
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In den WarenkorbZustand: 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.
EUR 149,47
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In den WarenkorbZustand: New. DAVID M. BLIESNER, Ph.D., is Founder and President of Delphi Analytical Services, Inc. He provides CGMP consulting and training services to the pharmaceutical, biopharmaceutical, contract analytical laboratory, and allied industries. He possesses a unique c.
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
EUR 197,51
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In den WarenkorbHardcover. Zustand: Brand New. 302 pages. 9.00x6.25x1.00 inches. In Stock.
Anbieter: Kennys Bookstore, Olney, MD, USA
EUR 218,47
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In den WarenkorbZustand: New. 2020. 1st Edition. Hardcover. . . . . . Books ship from the US and Ireland.
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Buch. Zustand: Neu. Neuware - Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operationsIn Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System.Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text.In addition to these topics, it includes LCS information and tools such as:\* End of chapter templates, checklists, and LCS guidance to help you follow the required standards\* Electronic versions of each tool so users can use them outside of the text\* An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systemsFor quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.