Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing.
Effectively managing recalls reduces regulatory risk and allows problem recovery to begin more quickly. The stakes are high and growing even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety. A part of the safety equation is looking at recalls. This seminar will explore key concepts in helping your company stay ahead of the regulatory curve by understanding FDA operations and developing effective mitigations to reduce risk in the recall area.
Why you should attend:
Understanding FDA's processes and how they view recall actions provides companies with invaluable information for conducting and managing effective recalls. When recalls are necessary but such action is not taken or not handled properly by a company, FDA treats this seriously by carefully evaluating the potential health risk involved. This can lead to an Agency requested or mandatory recall and possibly enforcement action including device seizure, injunction, and consent decree.
Additionally, effective recalls will help reduce both negative perception of your devices and financial pressures associated with removing devices from the market or correcting them. They will also facilitate more rapid recovery from the problems that led to the recall. Here is your chance to better understand how FDA thinks and operates and what their key areas of focus and priority are from a former Compliance insider.
Areas Covered in the Session:
What is a Recall?
How to determine if you have a Medical Device Recall
What can FDA do when a firm is reluctant to conduct a recall?
Things to Consider When Recalling Your Medical Device
Who can initiate a Medical Device Recall?
Who Will Benefit:
Clinical Trial Physicians and Professionals
Managers to Senior Directors in Reg. Affairs, QA, Clinical Research, and Data Monitoring
Institutional Review Boards
Small business owners
Larry Spears is a former CDRH Office of Compliance Director and Manager with over 20 years experience in administering regulations for the medical device industry and is currently an independent consultant to the medical device and pharmaceutical industries. His expertise in the exports area is derived from his years at CDRH where he made regulatory decisions that impacted the export program and the industry governed by it.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/29gQ0zk
LinkedIn Like us – https://www.linkedin.com/company/compliance4all-trainings
Twitter Follow us – https://twitter.com/compliance4all
Facebook Like us – https://www.facebook.com/Compliance4all
Pinterest - https://in.pinterest.com/compliance4all/