Current Good Manufacturing Practices Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference
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Description: FDA Regulations and Associated Guidance Documents:- Part 11 Electronic Records; Electronic Signatures- 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- Part 200 Drugs General- Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution- Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs- Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals- Part 600 Biological Products: General- Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices- Part 820 Quality System RegulationReference Tools:- Glossaries combined in one location- GMP Keyword Index for 21CFR211- Combined Index for all documents
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All the information you need in one place! Each Study Brief is a summary of one specific subject; facts, figures, and explanations to help you learn faster.
List price: $42.99
Publisher: CreateSpace Independent Publishing Platform
Publication date: 9/17/2009
Size: 6.00" wide x 9.00" long x 1.75" tall