Proactive Supplier Management Using Quality Agreements – Webinar Recording/Transcript
Do your supplier and contractor quality agreements protect you from problems beyond your control? Will the FDA hold you accountable when your third-party providers go awry?
By assessing risk and proactively pursuing air-tight supplier quality agreements, you can avoid regulatory peril and ensure compliance with the latest rules, such as the EU’s Medical Device Regulation, ICH Q10, and FDA vendor qualifications.
In this must-attend presentation by quality and supplier management expert James Shore, you’ll learn how to ensure your providers adopt the quality standards that will be most beneficial to your business.
Shore explains how to effectively use a risk assessment approach to determine the “level of intensity” needed in your quality agreements and provides a quality agreement template to use for compliance with the EU’s Medical Device Regulation. You’ll also come away with essential guidance on how to work towards ISO certification.
- Understand the regulatory requirements for quality agreements
- Understand how effective quality agreements not only meet requirements, but also provide additional business protection from regulatory enforcement action
- 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
- Review sample agreements to recognize key points to include in your quality agreements
To ensure your quality agreements provide you with the most protection, don’t miss this chance to gain key insights from a top expert in the field.
Meet Your Presenter
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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Dec. 7, 2023