Transparency and the New Medical Device Reporting Rules – Webinar Recording/Transcript

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Transparency and the New Medical Device Reporting Rules: What to Do Now That ASR is Really Over

Want to attend the live webinar on Oct. 4?  Click here to register.

Do you have a handle on the changes you may have to make to your MDR
program as a result of the Voluntary Malfunction Summary Reporting (VMSR) program?

And do you know how the FDA’s National Evaluation System for Health Technology (NEST) will impact you?

If you’re at all unsure, this presentation will deliver exactly what you need to ensure your organization’s MDR program is keeping pace with the changes brought by VMSR and NEST.

Two authorities from BioTeknica, Inc. — Julie Larsen, Principal Consultant and Director of Inspection Readiness Services and Lenita Sims-Spears, Esq., Senior QARA Consultant — will explain the implications for your organization and what to do to ensure you remain compliant.

Presentation Takeaways:

  • The real-world impact new medical device reporting programs will have following the formal end to the ASR program.
  • How the FDA is transitioning to the VMSR program.
  • Which devices and device malfunctions are eligible, or not, for summary reporting in VSMR.
  • Which events still require individual malfunction reports.
  • How to request summary reporting in VMSR.
  • The critical components of FDA’s NEST initiative — including how the agency will deploy real-world data to rapidly identify and address safety signals for devices on the market.
  • How the FDA will monitor medical device performance through NEST.

This presentation is the best way to understand the reporting process updates you may need to make so you can keep pace with VMSR and NEST.

  • Quality Professionals (Managers, Directors)
  • Regulatory Professionals (Managers, Directors)
  • Individuals Responsible for MDR Reporting
  • Compliance Professionals

Meet Your Presenters

Julie Larsen, Principal Consultant and Director of Inspection Readiness Services, BioTeknica, Inc.
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 25 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 and constructing responses and corrective action plans for Consent Decree, Warning Letter and Form 483 responses as well as development of quality systems. Prior to BioTeknica, she held senior management positions including Senior Director, Compliance & Auditing and Director, Quality Commercial Operations at Abbott Diagnostics; Director, Quality for Abbott Hematology; Compliance Auditor, Abbott Corporate Regulatory & Quality Science; and GMP Compliance Officer, Abbott Pharmaceutical Products.

Lenita Sims-Spears, Esq., Senior QARA Consultant, BioTeknica, Inc.
Lenita Sims-Spears, Esq. has been a Senior QARA Consultant with BioTeknica, Inc. for the past five years. She has 30 years’ experience in the medical device and pharmaceutical industry and has held roles of increasing responsibility for leading medical device companies worldwide, including Senior Director, Senior Manager and Program Lead. She is certified as a Lead Auditor and maintains her affiliations with ASQ, RAPS and FDLI. Ms. Sims-Spears is also a licensed attorney in Illinois and an adjunct professor at the John Marshall Law School in Chicago.