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What the Proposed Harmonization with ISO 13485 Means for Devicemakers Webinar on April 27, 2022

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FALLS CHURCH, Va. (PRWEB)

FDA’s New Quality Management System Regulation:

What the Proposed Harmonization with ISO 13485 Means for Devicemakers

An FDAnews Webinar

Wednesday, April 27, 2022, 1:30 p.m.–3:00 p.m. EDT

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

Get ready 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 well in motion.

Harmonization means changes. It can mean success if devicemakers understand the differences between QSR and ISO 13485, they can adjust the quality management system (QMS) accordingly and participate during the QMSR comment period.

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 further explain the proposed QMSR for the May 24 deadline, so devicemakers can adjust their QMS and reap the benefits of harmonization, by explaining:


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


a. The difference between being able to demonstrate competence of personnel vs. providing evidence of training

b. 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 the 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 in 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 is needed to adopt the new requirements and how the FDA will enforce them during the transition period

Get ready for the new QMSR and all its possibilities with this webinar.

Webinar Details:

FDA’s New Quality Management System Regulation:

What the Proposed Harmonization with ISO 13485 Means for Devicemakers

An FDAnews Webinar

Wednesday, April 27, 2022, 1:30 p.m.–3:00 p.m. EDT

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

Tuition:

$287 per site

Easy Ways to Order:

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

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

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 FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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