Current Good Manufacturing Practices : Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edition

Lingua: inglese

Editore: Pharmalogika Books Feb 2018, 2018

1937258173 / 9781937258177

Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH

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Venditore AbeBooks dal 14 agosto 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.

Codice articolo 9781937258177

Titolo
Current Good Manufacturing Practices : Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edition
Autore
Mindy J Allport-Settle
Editore
Pharmalogika Books Feb 2018
Anno di pubblicazione
2018
Condizione
Neu
Rilegatura
Taschenbuch
Lingua
inglese
ISBN 10
1937258173
ISBN 13
9781937258177
Peso dell'articolo
903 grammi
Dimensioni
229x152x35 mm

AHA-BUCH GmbH

Einbeck, Germania

Venditore con 5 stelle

Venditore AbeBooks dal 14 agosto 2006

Tariffe di spedizione da Germania a U.S.A.

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