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PRESS RELEASE: Paid content from Business Wire
Press release content from Business Wire. The AP news staff was not involved in its creation.

Three Day Course: Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls (October 21-23, 2021) - ResearchAndMarkets.com

May 26, 2021 GMT

DUBLIN--(BUSINESS WIRE)--May 26, 2021--

The “Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls” conference has been added to ResearchAndMarkets.com’s offering.

This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

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By attending this seminar, you will discover:

  • How to overcome one of the biggest obstacles device manufacturers face
  • How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling, and documentation
  • How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
  • How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall, and key factors in implementing and maintaining compliance with the regulations and real-life experiences of FDA.

**New course materials have been added, updated content will include:

  • Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
  • What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only WCS can provide.

Learning Objectives

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  • Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA’s handling of reports
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • A step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

For more information about this conference visit https://www.researchandmarkets.com/r/o3hsi4

View source version on businesswire.com:https://www.businesswire.com/news/home/20210526005570/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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KEYWORD:

INDUSTRY KEYWORD: FDA HEALTH MEDICAL DEVICES

SOURCE: Research and Markets

Copyright Business Wire 2021.

PUB: 05/26/2021 07:12 AM/DISC: 05/26/2021 07:12 AM

http://www.businesswire.com/news/home/20210526005570/en