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Managing supply chain risk under FDA’s QMSR final rule
Join us for an in-depth look at managing supply chain risk under FDA’s QMSR. Since the final rule of FDA’s QMSR passed, harmonizing with ISO 13485, an increased emphasis has been placed on the management of risk. Arguably, nothing poses a greater risk to medical device organizations and to healthcare product availability than risks in the supply chain. Something so business-critical that can be affected by events that seem out of your organization’s control can feel alarming.
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key takeaways
What you will learn
- You will gain an in-depth understanding of supply chain risks
- Learn about the role and mission of FDA in ensuring healthcare product availability
- Get an outline of the supply-chain-specific requirements in QMSR
- Gain an insight into using electronic systems for the upkeep of a healthy, secure supply chain
- Get expert insight into which goals should be prioritized when assessing and managing supply chain risk
- Insight into the role healthcare supply chain risk plays in relation to 21 CFR 820 and ISO 13485
- Learn how to build supply chain resilience and avoid disruptions
- A summary of the regulatory landscape and key expectations that protect healthcare supply chains
About this webinar
Discover Managing supply chain risk under FDA’s QMSR final rule Program
That’s why in this webinar, we’ll be looking at how you can build a resilient supply chain that will help your organization to ride the waves of supply chain instability. From building strong relationships with suppliers and manufacturers, to creating a robust quality management system as a foundation for a secure supply chain, join Ideagen and Joanne Rupprecht for an insightful webinar on how to manage risk and challenges ahead.
Meet our speaker
Joanne Rupprecht
Founder, Rupprecht Consulting Services, LLCJoanne Rupprecht, a seasoned leader in regulatory affairs, federal agency/life sciences law, and higher education, boasts 35+ years in healthcare product development across academia and industry. Proficient in domestic (FDA) and international regulatory affairs, quality systems, and CAR T Cell/stem cell therapies, Jo honed skills at the University of Illinois, University of Chicago, Abbott Labs, and earned a Juris Doctor at Denver Sturm College of Law.
With Seton Hall's Life Sciences Compliance Certification, U.S. and Global RAC, ACRP-CP, and CCEP credentials, Jo crafts programs and has written for RAPS. She teaches Biomedical Entrepreneurship and The Regulatory Environment at the University of Colorado, Denver, and serves BESST Program. Bridging science, business, and law, Jo aids healthcare pioneers in intricate regulatory landscapes, adeptly evaluating business risks, policies, and governmental influences to ensure compliant operations.
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