Why Is CDRH’s eCopy Confusing Everybody?
March 15, 2013 Avoid the CDRH eCopy Chaos! CDRH now requires eCopy for every submission since Jan. 1. According to electronic submissions expert Antoinette Azevedo, there have been instances of many eCopy holds at CDRH because of so many issues with the new format of eCopy. A hold means a delay, which means loss of […]
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Get Out of FDA’s Crosshairs – Move to Kansas!
March 19, 2013 Want less FDA attention? Consider Kansas. Our recent Webinar on FDA inspections with Dennis Moore, AUK Technical Services, was quite eye opening. Dennis is one of the few consultants that really focuses on the FDA district office level to see what they are up to in terms of writing 483s and warning […]
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Inspection Tip – Please Don’t Put the FDA Investigator in the Boiler Room
March 14, 2013 Â The $100,000 FDA Compliance Disaster Please don’t do this to your FDA investigator. Every time I have Dennis Moore for one of his excellent FDA inspection webinars, I marvel at some of the mistakes that some really bright folks make in the pharmaceutical industry during an inspection.It’s interesting how some of the […]
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Avoid a CAPA File Inspection Disaster
March 18, 2013 We had a very informative webinar with Dennis Moore, AUK Technical Services, this month on surviving an FDA inspection….lots of interesting war and horror stories, things to do and not do. We also have this interesting Webinar coming up on how to design a closed-loop CAPA system. One that was interesting to […]
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How the Quality Manager Gets Fired aka The $100,000 FDA Compliance Mistake
March 12, 2013 It always amazes me. The pharmaceutical industry is full of some of the brightest and most dedicated professionals in any industry anywhere. However, some of the simplest FDA regulations can trip up some very smart people at some very big companies. The biggest example I can think of is one that our […]
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Don’t Put Your Pharma Company in LA?
March 14, 2013 The $50,000 FDA Compliance Mistake! One of the most interesting pieces of pharmaceutical-related information we have seen recently is how differently the various FDA district offices behave. There is no doubt about it: Some FDA district offices are more strict than others. For example, in 2011, the LA district office issued 14 […]
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The Silent Treatment and Other Classic FDAer Tricks
March 19, 2013 We hear a lot about tricks that FDA auditors like to use to get information out of companies. One of the most common is when they give you ‘the silent treatment’ during the inspection or at the conference table. The idea is for them to be quiet and wait for you to […]
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Big FDA Challenges Ahead in 3D Printing and Nanobots
3D Printing and Nanobots – FDA Challenges Ahead Among many products, the US Food and Drug Administration (FDA) regulates medical devices such as stents and prosthetics. FDA regulations – and compliance – are predicated on an assumption that medical device production is an involved undertaking that requires expertise, monies, and physical manufacturing. Yet, what would […]
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Managers: Spend $14,000 on a Mock Audit, or $480,000 on a Warning Letter Clean Up?
March 24, 2013 It might seem obvious, but the role of senior company leadership in FDA compliance is to really participate in the company’s quality system design and oversight. You need to ensure continual improvement of all of your quality system operations. One of the reasons this is so true is that according to recent […]
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Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement
March 6, 2013 Our recent excellent FDA compliance speaker, Dennis Moore, President, AUK Technical Services, had some great data on the latest FDA compliance trends, including the most common areas where companies are getting 483s. If you’ve ever dealt with the agency, you know how difficult it can be to extract recent data from them […]
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