FDAnews Announces — Medical Device Change Management Webinar, April 16, 2020

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Master medical device change management to ensure the quality management systems (QMS) are efficient and effective.

WCG FDAnews

WCG FDAnews

Medical Device Change Management
An FDAnews Webinar
Thursday, April 16, 2020, 1:30 p.m. - 3:00 p.m. EDT
https://www.fdanews.com/mdchangemanagement

What change management method should one be using for a medical device?

The answer is, it depends — the method is often dependent on the type of change. Is it due to post-market design change, production process changes, QMS process changes, corrective action or preventive action?

If one is involved in any aspect of quality management systems (QMS), one needs to be familiar with the overarching change management process as well as common methods for specific change types.

Join FDAnews and operational expert Dan O’Leary for a comprehensive overview on April 16. Mr. O’Leary will review best practices, processes and methods to support medical device change management. The presentation will cover change activities in FDA QSR, ISO 13485:2016, EU-MDR Article 10, and EU-IVDR Article 10:

●Familiarize oneself with the overarching change management process and methods
●Assess how to apply the process to specific change types
●Determine the change interactions in the change types
●Master how to apply the process to specific QMS requirements
●Identify the similarities and differences across QMS requirements

Bonus material: Participants will receive a guide to the change management process and its applications.

Ensure a consistent approach to the change management process and avoid problems associated with ad hoc methods.

Webinar Details:
Medical Device Change Management
An FDAnews Webinar
Thursday, April 16, 2020, 1:30 p.m. - 3:00 p.m. EDT
https://www.fdanews.com/mdchangemanagement

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/mdchangemanagement
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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Michelle Butler
FDAnews
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