Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes
Product Details
Maintaining quality in your drug products and medical devices is all about managing risk—identifying it, assessing it and knowing how to prevent it.
To stay on top of production, you need a go-to reference that helps you understand all the FDA’s guidances and reports on risk management that affect your manufacturing operations.
FDAnews’ Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes has all the references you need in one handy volume. The guide has more than 400 pages of FDA requirements and 20 specific documents that include guidances, statements and policies.
Purchase this guide today to get help on key issues, including:
- Assessing requirements for risk evaluation and mitigation strategies (REMS)
- Format and content of a REMS submission
- Using a drug master file for shared-system REMS submissions
- Benefit-risk counseling of patients using a drug with a REMS
- Determining how to develop a risk minimization action plan
- Identifying how to conduct a health hazard evaluation
- Evaluating pre-marketing risk
- Meeting FDA-adopted international standards
- ISO 10993 on the biological evaluation of medical devices
- ICH Q9 on quality risk management
- ICH Q10 on pharmaceutical quality systems
Why pay a consultant to find the risk management information you need when FDAnews has collected it all in one volume? Order your copy today.
Who Will Benefit
- Drug and device manufacturers
- Contract manufacturers
- API manufacturers
- Any company with an FDA-regulated quality management system
- Quality managers
- Regulatory and compliance personnel
- Senior-level executives
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ISBN-13:
978-1-60430-127-4
Publication date:
April 2020
Page count:
497
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