Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on November 06 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

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.

Choose a Purchase Options


$249

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Live Corporate Group Up to 5 Participants ( Recorded Access Included )

Up to 5 Participants

Up to 5 Dial In is allowed from home or office .

$299

On Demand Access 6 month

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period for a group. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session.

$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.