Product Details
It’s finally here! The FDA has unveiled the long-awaited final rule to align the 27-year-old Quality Systems Regulation (QSR) with the ISO 13485 international standard. How will this development change the way you manage your quality system?
The new Quality Management System Regulation (QMSR) requires all U.S. medical device manufacturers to transition from the legacy QSR to the QMSR. When that transition period ends, the agency will no longer accept QSR-compliant records that conflict with the QMSR.
Get full details of the FDA’s expectations for the transition along with expert insights into the new QMSR by listening to this FDAnews webinar recording, led by Eric Henry, senior quality systems and compliance advisor of the FDA & Life Sciences Practice at the King & Spalding law firm. Henry will also provide insider-only knowledge of how the FDA reacted to comments made to the proposed rule, and more..
Presentation Takeaways:
- The drivers leading to the U.S. harmonization with ISO 13485:2016
- How the QMSR incorporates ISO 13485:2016
- How the QMSR differs from ISO 13485:2016
- The FDA’s new inspection scheme replacing the current Quality System Inspection Technique (QSIT)
Don’t miss the chance to gain key insights from a thought leader in the field and ensure a smooth transition to the new system.
Meet Your Presenter
Eric Henry, Senior Quality Systems and Compliance Advisor of FDA & Life Sciences Practice at King & Spalding law firm, is a veteran of the industry of more than 33 years. Since 2018, he has provided advisory and consulting services focused on regulatory compliance, enforcement and policy matters for industries regulated by the FDA. Henry delivers topnotch guidance on FDA requirements to professionals in medical device manufacturing, including but not limited to quality systems requirements, inspection preparedness and post-market obligations. He also advises corporate management and boards on their responsibilities and expectations of the FDA.
Who Will Benefit
- All levels of leadership at medical device companies
- Quality assurance staff
- Regulatory affairs staff
- General counsel