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Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections / Vera Mihajlovic-Madzarevic

(John Wiley and Sons, 2010)

 Abstrak

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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Jenis Koleksi : eBooks
No. Panggil : e20376693
Subjek :
Penerbitan : Hoboken, New Jersey: John Wiley and Sons, 2010
Sumber Pengatalogan: LibUI eng rda
Tipe Konten: [computer dataset ]
Tipe Media: [computer ]
Tipe Pembawa: [online resources ]
Deskripsi Fisik:
Tautan: http://onlinelibrary.wiley.com/book/10.1002/9780470572757
Lembaga Pemilik:
Lokasi:
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