Current Good Manufacturing Practices : Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edition
Language: English
Published by Pharmalogika Books Feb 2018, 2018
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
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Neuware - FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR 11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR 26) - Part 200 Drugs: General (21CFR 200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR 207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR 210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR 211) - Part 600 Biological Products: General (21CFR 600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR 807) - Part 820 Quality System Regulation (21CFR 820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents.…
Seller Inventory # 9781937258177
- Title
- Current Good Manufacturing Practices : Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edition
- Author
- Mindy J Allport-Settle
- Publisher
- Pharmalogika Books Feb 2018
- Publication year
- 2018
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 1937258173
- ISBN 13
- 9781937258177
- Item weight
- 903 grams
- Dimensions
- 229x152x35 mm
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