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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FDA Calls for Corporate Commitment and Leadership at PolyCarbon Industries
Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership. We have reported before that the FDA expects corporate oversight of the Quality Management System. The Johnson & Johnson debacle is just […]
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Compliance Tips For cGMP Inspections
Successfully managing a cGMP inspection begins first with developing a clear cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection. Because the FDA can arrive at your company without any prior notification, it is important that you thoroughly, and regularly train and prepare all personnel, […]
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FDA Inspection Wizard – What’s Scary Can Turn Out to Be a Piece of Cake
Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance. Here we […]
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How to Perform a Mock Audit
After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria established by the FDA and on the type of work your company does; for example, a good option would […]
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