Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections / Vera Mihajlovic-Madzarevic
(John Wiley and Sons, 2010)
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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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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: |
No. Panggil | No. Barkod | Ketersediaan |
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e20376693 | TERSEDIA |
Ulasan: |
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