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CDRH Enforcement Trends: Back to the Future
As Winston Churchill said, “Those who don’t learn from history are doomed to repeat it.”
If you analyze CDRH’s enforcement actions in 2015, you’ll get a pretty good idea of what to expect when they come knocking this year. But that takes time. So we’ve done it for you.
Take a close look at the warning letters the agency sent last year, and you’ll see the usual suspects — GMP lapses, poor CAPA practices, quality audit issues — but you’ll also find a more laser-like focus on device makers who don’t seek premarket approval for alternative uses of their products. Also raising its head — a lack of or inadequate employee training and an old standby that can’t be possibly be ignored — lack of or inadequate procedures.
Your SOPs need to be simple enough to follow yet complete enough to satisfy intense scrutiny. It’s better to have a simple flowchart that you follow than a 30-page tome that looks great on paper but has dust settling on the cover due to lack of use.
The bottom line is that warning letters tend to cause a drop in company evaluation and a drop in company revenue – your executive team, your shareholders, and your patients don’t want to see a warning letter with your company name on it.
If you’re a candidate for inspection or you just want to be prepared in case an FDA inspector has you on a list, you’ll want to join the presentation which will detail exactly what FDA enforcers were focusing on last year. It will also project forward to let you know what you’re likely to see from them when they come and visit your facility this year.
John Avellanet, Founder, Cerulean Associates LLC
John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.
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