Product Details
One of the FDA’s top inspection observations is inadequate purchasing controls, including lax oversight of suppliers. To be fully compliant, the agency expects to see risk-based supplier quality agreements — not just cookie-cutter documents that simply repeat standard regulatory language.
By proactively pursuing air-tight supplier quality agreements, you can avoid regulatory peril, manage risk and earn bragging rights for complying with the ICH Q10 as well as FDA vendor qualifications. Risk-based supplier quality agreements are also essential if you’re working towards compliance with the EU’s Medical Device Regulation or if you’re seeking ISO certification.
Supplier Quality Agreements: A Risk-Based Approach, a management report from FDAnews, A WCG Company, digs into the details to give you confidence in crafting quality agreements that comply with the latest regulatory requirements.
Report Takeaways:
- Master the regulatory requirements for quality agreements
- Recognize how effective quality agreements not only meet requirements, but also provide additional business protections from regulatory enforcement actions
- Learn how to use risk-assessment methods to determine the “level of intensity” needed in an agreement, based on the type of supplier or contractor being used
- Review sample agreements, and learn to recognize key points to include in your own quality agreements
Supplier Quality Agreements: A Risk-Based Approach provides the essential guidance you need to develop a gold-standard method for creating risk-based supplier quality agreements. Order your copy today.
About the Contributor
James Shore, Chief Quality Officer, Quality Lean Solutions
James Shore is the Chief Quality Officer of Quality Lean Solutions (QLS), which serves the medical device and high-tech industries, providing value-added auditing, lean manufacturing, development of quality management systems, assistance with the EU Medical Device Regulation transition, and performance of inspections to the American Association of Tissue Banks standard. He has more than 30 years of quality and supplier management experience working in medical devices, semiconductors, aerospace and defense. Shore is also coauthor of Proactive Supplier Quality Management in the Medical Device Industry, published by Quality Press.
Who Will Benefit
- Quality engineers
- Regulatory engineers
- Medical affairs
- Project/program managers
- Medical device QMS auditors
- Supply chain engineers
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Contributor:
James Shore
ISBN:
978-1-60430-227-1
Publication date:
Feb. 2024
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