Health

FDA’s New Quality Management System Regulation Webinar on September 22, 2022

Leave a comment



FALLS CHURCH, Va. (PRWEB)

FDA’s New Quality Management System Regulation:

What the Proposed Harmonization with ISO 13485

Means for Devicemakers

An FDAnews Webinar

Thursday, Sept. 22, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/fdas-new-quality-management-system-regulation

Medical device manufacturers need to take advantage of the FDA’s proposed Quality Management System Regulation (QMSR).

No longer a far-off possibility, harmonization of the FDA’s Quality System Regulation (QSR) with ISO 13485 is underway.

Harmonization means changes. It can also mean success, if manufacturers understand the differences between QSR and ISO 13485, and adjust their quality management system (QMS) accordingly.

Kristen Grumet, senior vice president of regulatory compliance at Greenleaf Health, has nine years’ experience as an FDA field investigator specializing in medical devices. She will ensure attendees understand the proposed QMSR and adjust their QMS to gain the benefits of harmonization by explaining:


  • The commonalities and differences between ISO 13485:2016 and the FDA’s proposed QMSR, including:


*The difference between demonstrating competence of personnel vs. providing evidence of training

*The expectations for risk management and a risk-based approach throughout the QMS vs. the use of risk analysis during design controls

  • The commonalities and differences between how quality system requirements are enforced by the FDA vs. notified body auditors (e.g., auditing styles and potential regulatory repercussions of noncompliance)

  • The history and driving force behind harmonization: why the FDA is changing the QSR now after more than 20 years of successful implementation

  • The advantages and potential disadvantages of harmonization, such as how the satellite regulations of Part 803 (MDR Reporting) and Part 806 (Corrections and Removals) fit under ISO 13485:2016 and what happens to the FDA’s Quality Systems Inspection Technique (QSIT) program

  • What to expect during the transition from the current QSR to the new QMSR, including how much time manufacturers will have to adopt the new requirements and how the FDA will enforce them during the transition period

Webinar Details

FDA’s New Quality Management System Regulation:

What the Proposed Harmonization with ISO 13485

Means for Devicemakers

An FDAnews Webinar

Thursday, Sept. 22, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/fdas-new-quality-management-system-regulation

Price:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/fdas-new-quality-management-system-regulation

By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:

WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews’ newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations. Learn more at fdanews.com.

Share article on social media or email:

Leave a Reply