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Preparing for FDA Pre-Approval Inspections
- A Guide to Regulatory Success, Second Edition
Engelsk
Bogcover for Preparing for FDA Pre-Approval Inspections af , 9780367452711
Specifikationer
Sprog:
Engelsk
Sider:
304
ISBN-13:
9780367452711
Indbinding:
Paperback
Udgave:
2
ISBN-10:
0367452715
Udg. Dato:
2 dec 2019
Størrelse i cm:
22,9 x 15,2
Oplagsdato:
2 dec 2019

Preparing for FDA Pre-Approval Inspections

- A Guide to Regulatory Success, Second Edition
Engelsk
Paperback 2019
Format:

Bog beskrivelse

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
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Specifikationer
Sprog:
Engelsk
Sider:
304
ISBN-13:
9780367452711
Indbinding:
Paperback
Udgave:
2
ISBN-10:
0367452715
Udg. Dato:
2 dec 2019
Størrelse i cm:
22,9 x 15,2
Oplagsdato:
2 dec 2019
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