Twelfth Annual Medical Device Quality Congress

precon

8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 12:00 p.m.

Integrating Risk Management Into Complaint Management And CAPA Processes

The importance of integrating risk management into your processes can’t be overstated, and more and more devicemakers are seeing that its effective application helps them better prioritize and focus on their most important concerns – especially with CAPA and complaint management. With complaints on the rise (thanks to social media) and the FDA’s high expectations of your CAPA program, embracing the tenets of risk management to improve your processes is a no-brainer. Attend this in-depth session – taught by a risk management expert who deals with complaint management and CAPA every day – and you’ll return to your office filled with newly-acquired knowledge and ready to move into a leadership role in this always difficult area.

Attendees will learn:

  • Understanding how to review complaints and CAPAs with a risk management mindset to prioritize valuable time and resources
  • Creating and writing SOPs that govern and explain how you integrate risk management to manage complaints and CAPAs — the FDA will expect to see these during an inspection
  • Managing emerging sources of complaints and applying risk management tools to determine how best to handle them

Larry Kopyta, Vice President, Quality Assurance & Regulatory Affairs, Omnyx
Bob Marshal, Director of Business Development, Regulatory & Quality Solutions, LLC

 

register

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