No company wants its product recalled by the U.S. Food and Drug Administration, but it can happen despite the most careful product planning.
How a company handles such a recall can make or break its relationship with the FDA, not to mention its reputation with the public. As an FDA recall may be the ultimate test of a firm’s crisis management strategies, ResearchandMarkets.com is offering help in creating and implementing those strategies.
A former FDA official will be the featured presenter at a two-day seminar slated for May 16 and 17 in Mebane, North Carolina, offered by ResearchandMarkets.com.
At “FDA Recalls: Before You Start, and After You Finish — 2-Day In-Person Seminar by Ex-FDA Official” participants will learn how the FDA’s recall program works, how to comply with agency requirements, and how to identify the underlying reason for the recall (one recall is not great, two is exponentially more difficult to overcome), and more.
“Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, ‘You don't get it,’” ResearchandMarketing.com said in a press release announcing the seminar.
“Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.”
Not only producers of devices and pharmaceuticals, but also other industries — such as hospitals, nursing homes and other health care providers as well as importers and distributers — are affected by recalls, need to understand the process and the seminar is geared to their managers, quality control managers and others who have input into the recall process.