この商品を友人に教える:
Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition 第2 版
価格
¥ 16.625
税抜
遠隔倉庫からの取り寄せ
発送予定日 年12月1日 - 年12月17日
クリスマスプレゼントは1月31日まで返品可能です
iMusicのウィッシュリストに追加
Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition
This Second Edition is an essential guide to preparing for FDA pre-approval inspections?taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
- chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
- demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
- focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility
304 pages
| メディア | 書籍 Paperback Book (ソフトカバーで背表紙を接着した本) |
| リリース済み | 2019年12月2日 |
| ISBN13 | 9780367452711 |
| 出版社 | Taylor & Francis Ltd |
| ページ数 | 304 |
| 寸法 | 150 × 220 × 10 mm · 453 g |
| 言語 | 英語 |
| 編集者 | Hynes, Martin D. |
