Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
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| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
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| Subjects: | |
| Online Access: | https://biblioteca.ues.edu.sv/acceso/elibro/?url=https%3A%2F%2Felibro.net%2Fereader%2Fbiblioues/179616 View in OPAC |
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Table of Contents:
- Controlling regulatory costs
- Clear operation definitions of requirements
- Pre-regulatory audits
- Quality by design
- Outsourcing
- Electronic submissions
- Emea/fda coordination
- Managing FDA inspections
- Risk assessment
- Cases
- Cost containment analysis
- Managing regulation in times of chaos
- International regulation
- Cost contained regulatory compliance.