Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes, 2024 Edition
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 do that, 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.
This new 2024 edition, last updated in 2020, features more than 500 pages of FDA requirements and 21 specific agency guidances, statements and policies. It includes new guidance on the Format and Content of a REMS and on significant international standards, such as ICH Q9(R1) Quality Risk Management and ISO 10993-1 Biological Evaluation of Medical Devices.
Purchase this guide today to get help on key issues, including:
- Assessing requirements for risk evaluation and mitigation strategies.
- Determining how to develop a risk-minimization action plan.
- Identifying how to conduct a health-hazard evaluation.
- Evaluating pre-market risk.
- Meeting FDA-adopted international standards, such as:
- ISO 10993 on the biological evaluation of medical devices
- ICH Q9 on quality risk management
- ICH Q10 on pharmaceutical quality systems
A foundational volume for manufacturers and the consultants that serve them, FDAnews’ Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes, 2024 Edition has all the references you need in one handy 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:
978-1-60430-228-8
Publication date:
March 2024
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