YourEncore Insights - Life Sciences

FDA 483 Responses: Avoiding Common Pitfalls and Deficiencies (Ep. 8 on The Pharmcast)

Posted by Jim Combs on 1/12/17 8:00 AM

Pharmcast_Ep8_HeroImage.png

This week on The Pharmcast, we explore best practices and common pitfalls in FDA 483 Responses. 

In 2015, there were an average of 175 inspections and 10 warning letters issued per month by the Center for Devices and Radiological Health alone.  Regulatory inspections and 483 findings are a part of being a life sciences company.  However, how companies respond can have a major impact on patient safety and business performance.

To share best practices, we held a special presentation with two of our top medical device experts, Victor Chance and Judy Meritz, to outline what they’ve learned over the course of their 20+ year careers in the medical devices industry.

Victor Chance is the former VP of External Operations and Chief Supply Chain Chief Procurement Officer for J&J Medical Devices and Diagnostics. Victor also served as Worldwide Vice President of Operations for J&J’s Cordis franchise and was responsible for directing the company’s global manufacturing, supply chain management and strategic sourcing functions. 

Judy Meritz, J.D., was the Associate General Counsel at Covidien/Medtronic and specializes in compliance counseling concerning FDA and other international regulatory authority matters including inspections, enforcement actions, product approval strategies, marketing and advertising programs, and complaint handling. 

We join the presentation with Victor Chance, who outlines his success roadmap to an effective 483 response.  If you would like to see the recorded presentation, you can watch here.   

If you have topics you would like YourEncore to explore on future episodes of The Pharmcast, please email Pharmcast@yourencore.com with feedback or suggestions.

The Pharmcast is now available for download on iTunes, Google Play, and Stitcher. If you like what you hear, share it with your friends and write a review or give us a rating on your podcast store. 

pharmcast_cta.png

Topics: Medical Device, Med Dev, FDA, Supply Chain, Pharmcast