CDRH’s Proposed Rule Harmonizing QSR and ISO 13485: Everything Devicemakers Must Know and Do to Prepare – Webinar Recording/Transcript
Will you know what to do when CDRH harmonizes its quality system regulation (QSR) with ISO 13485? Prepare now or risk noncompliance.
Those who think the FDA is dragging its feet on harmonization, think again: in May, CDRH Director Shuren announced the agency’s efforts are back on track and a top priority after being sidelined, in part, by the pandemic. In fact, the draft proposed rule is due before the end of 2021.
This means devicemakers must incorporate more modern risk management principles and align quality systems more closely with ISO 13485 — and sooner rather than later. While the specific timing of the draft and final rule are unknowns, there are key changes you must understand now and strategic steps you can take to get ready.
Julie Larsen, a principal consultant and director of inspection readiness services at BioTeknica, Inc., will share these changes and steps so you can stay compliant.
- What the anticipated significant changes are, in the proposed rule will be, including the ways in which quality and ISO 13485 will be more harmonized
- The anticipated timing for the final rule and expectations for compliance, including more advanced risk management techniques
- Key changes devicemakers must make to their quality systems, including those that will be necessary to harmonize with ISO 13485
- What the implications will be to risk management processes in general, including how to devise systems to ferret out errors in quality control management
Wait for the draft proposed rule and you’re already behind. Prepare now and you’ll stay compliant.
Meet Your Presenter
Julie Larsen is a principal consultant and director of inspection readiness services at BioTeknica, Inc., a quality and regulatory compliance and engineering consulting firm in Coral Gables, Florida. She is a Certified Quality Manager (CQM), a Medical Technologist (MTASCP) and has more than 30 years’ experience in quality assurance and compliance in the medical device and pharmaceutical industries. Ms. Larsen has extensive experience in quality systems remediation for compliance improvement; constructing responses and corrective action plans for Consent Decree, Warning Letter and Form 483 responses; FDA inspection support; and development of quality systems.
Who Will Benefit
- Quality leaders (managers, directors, vice presidents)
- Regulatory affairs professionals
- Internal auditors
- Operations managers
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Nov. 30, 2021