Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg.
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Year of Publication: | 2011 |
Language: | English |
Online Access: | |
Physical Description: | ix, 284 p. :; ill. |
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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.