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Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry (Part 2 of 4)

Upcoming Webinar
Date: Wednesday, August 15, 2018 | Time: 10am EDT / 3pm BST / 4pm CEST (Europe)
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Dear ExampleContactFirstName,

This presentation will take a deeper look into the regulatory requirements for supplier management for the MedTech – medical devices and in-vitro diagnostics – industry.

The speaker will look further into ISO13485:2016 which increase the requirements for supplier management, especially the monitoring of suppliers. In addition, the speaker will cover the specific needs, by country, of the Medical Devices Single Audit Program (MDSAP), and will discuss what to expect from an MDSAP audit in relation to supplier management.

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Topics in this presentation include:
  • Overview of 21 CFR Part 820, providing guidance and industry views on how the FDA interprets purchasing controls
  • Further analysis of the most common FDA enforcement actions (483, Warning Letters)
  • Latest FDA statistics for 2018 YTD on the increasing number of product recalls for medical devices
More information
Featured Speaker:

Speaker 1
Phil Johnson
Senior Director, Quality and Compliance Services, IQVIA

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