What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation

Webinar
Life Sciences; Risk Management & Compliance

Date: 27 Oct '20
Time: 10:30am to 12:30pm (GMT-05:00) Eastern Time (US and Canada)
Price: Under 250 USD$

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Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Join us for a webinar on October 27 for a discussion of the webinar

Who Will Benefit

  • Regulatory compliance personnel
  • Quality managers and directors
  • Quality engineers
  • Risk management specialists
  • Regulatory managers
  • Design engineering managers
  • Supply chain managers focused on procurement and distribution
  • Production managers and engineers
  • Document control specialists
  • Marketing managers
  • Clinical managers
  • Clinical evaluation specialists
  • Export compliance managers

Agenda

The Internal Audit Program

  • ISO 19011:2018
  • ISO 13485:2016
  • Planning, conducting and reporting

 Conformity Assessment Paths

  • Device Specific Areas
  • QMS and risk management system (RMS)
  • The Annex I documentation
  • The Annex II and Annex III documentation
 
The Application to the NB

  • The NB Approach to the Audit

Integrating NB Approach with Internal Audits 

  • Conducting a mock audit
The deadlines for these new regulations are approaching quickly. Don’t miss this chance to gain expert advice on what can become a complicated, difficult, and long process—and do it all from the comfort of your own home.

Medical device regulations in the EU are changing and changing fast. If your business is global, you can’t avoid these crucial adjustments.

With one extension already granted, any organization selling devices in the region now need to be ready for the shift by May 2021. There’s little time to spare to get your processes up to par — but WCS can help get you there.

Join us for the Live Webinar on Tuesday, October 27, and learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management methods, including those around:

  • Internal Audit Programming: ISO 19011:2018 and 13485:2016
  • Conformity Assessment Paths and Device-Specific Areas: QMS and RMS; Annex I, II, and III
  • Applications to Notifying Bodies
  • Notifying Body Approach to Audits

Reserve your spot at this critical online training today.


David R. Dills

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification.

Organizer

WCS consulting inc

Organizer

WCS consulting inc

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