Książka Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections Vera Mihajlovic-Madzarevic

Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections

Język: Angielski
Oprawa: Twarda
Dostępność: Dostępna u dostawcy
Wysyłamy za 14-21 dni
475.32
All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applic...

Informacje o książce

Język
Angielski
Oprawa
Książka - Twarda
Data wydania
2010
strony
246
EAN
9780470248850
ISBN
0470248858
Enbook ID
04882483
Waga
490
Wymiary
156 x 234 x 16

Pełny opis

All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.

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