510(k) Change Analysis
Make the Guidance Documents Work for You

Thursday, Aug. 22, 2019 • 1:30 p.m. - 3:00 p.m. EDT

The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This webinar will provide you with a clear understanding of the decision paths and processes presented in the guidance documents, the information you need to write a solid SOP and the tools for effective implementation — helping you to stand up to an inspection.

Webinar Takeaways:

Industry expert Dan O’Leary, President of Ombu Enterprises, LLC, will present information on the guidance documents, including:

  • The role of risk management (ISO 14971:2007) in the evaluation process
  • The decision-making process embodied in the flowcharts
  • The criteria behind the flowchart decision boxes
  • How to keep quality records that support your decision

Bonus material! You’ll receive an Excel workbook, that implements the logic in the flowcharts, guiding you through the decision-making process and enabling you to provide sufficient documentation.

This webinar will show you how to develop a well-reasoned decision-making process and appropriate documentation to help avoid a 483. Join us by registering today.

Who Will Benefit

  • Design Engineering Managers
  • Design Project Managers
  • Design Engineers
  • Quality Managers
  • Quality Engineers
  • Documentation Specialists
  • Regulatory Affairs Specialists

Webinar plus USB Audio Recording/Transcript
Learn more

$487

add to cart

Webinar only
Learn more

$287

add to cart

24/7 Encore plus USB Audio Recording/Transcript
Learn more

$487

add to cart

24/7 Encore Presentation
Learn more

$287

add to cart

USB Audio Recording/Transcript
Learn more

$287

add to cart

 

Meet Your Presenter

Dan O’Leary

President
Ombu Enterprises, LLC

Dan O’Leary is the President of Ombu Enterprises, LLC. He has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Masters Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

 

MII logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

Phone (703) 538-7600 | Fax (703) 538-7676 | Toll free (888) 838-5578 | Email customerservice@fdanews.com

© 2019 FDAnews