FDAnews Announces -- 5 Design Change Considerations to Stay Compliant Webinar, June 6, 2019

Thursday, May 23, 2019 General News
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Changing the design of a medical device entails compliance with five separate regulations. Sort things out the easy way.

FALLS CHURCH, Va., May 23, 2019 /PRNewswire-PRWeb/ -- 5 Design Change Considerations to Stay Compliant An FDAnews Webinar

Thursday, June 6, 2019, 1:30 p.m. - 3:00 p.m. EDT https://www.fdanews.com/5designchange

Do devicemakers read the fine print when changing a design?

Changes are subject to several FDA regulations and failure to dot all the i's and cross all the t's may result in inspection failures as well as missed profit opportunities.

Spend 90 minutes with Dan O'Leary, FDAnews's top presenter on technical issues involving medical devices to resolve various pain points:

  • Relationship among design output, design transfer and production control
  • Reason why the FDA may deem a production change to be a design change
  • Elements of the new UDI rule including the Device Identifier (DI)
  • Triggers that create a new DI and how to document your decision
  • Requirement to evaluate change significance for possible 510(k) submission
  • Use of the 510(k) change guidance documents
  • Changes to the risk management file resulting from a design change
  • Implications for FDA inspections

Attendees need to know what amounts to a design change and how to implement it if one is responsible for production and process changes. Similarly, attendees need assistance on complete and compliant changes if one is responsible for design changes. Sign up for our event today.

Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details: Statistical Concepts of Process Validation **An FDAnews Webinar** Thursday, May 30, 2019, 1:30 p.m. - 3:00 p.m. EDT https://www.fdanews.com/5designchange

Tuition: $287 per site

Easy Ways to Register: Online: https://www.fdanews.com/5designchange 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.

 

SOURCE FDAnews



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