Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success
D. Hynes III Martin
This Second Edition is an essential guide to preparing for inspections-taking into account current trends in FDA expectations and enforcement activities, such as quality systems-based approach to inspections, risk-based inspections, and the GMPs of the 21st century to produce rapid regulatory approval.
카테고리:
년:
2008
판:
2
출판사:
Informa Healthcare
언어:
english
페이지:
306
ISBN 10:
0849391849
ISBN 13:
9780849391842
시리즈:
Drugs and the Pharmaceutical Sciences
파일:
PDF, 3.72 MB
IPFS:
,
english, 2008