More FDA Inspection Tips (And One Unforgettable Quote from the FDA Compliance Director)
March 26, 2013 After our recent very informative Webinar on FDA inspection tips, we asked some of our readers what the most important things are to avoid FDA 483s. Here are some of our favorite responses: Pre-Inspection It is important to practice inspection readiness on a daily basis. Run a mock audit often and review […]
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Tips to Perform Your Next Laboratory Quality Audit
March 26, 2013 It is always strongly advised that a laboratory conduct its very own internal quality audit every few months to make sure that test analyses always provide reliable results. By doing an internal audit, you also will provide your lab with detailed knowledge of how well it follows its own quality guidelines, and […]
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PDF Problems Reported With FDA’s New eCopy Rule
March 24, 2013 In the last 10 days, we have been reporting on some of the problems and confusion surrounding the new eCopy program by FDA. You can read our other reports on eCopy here, here and here. In eCopy, the agency seems to have a belief that PDFs are an open format that one […]
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The Death of Paper – FDA eCopy
March 24, 2013 The date Dec. 30, 2012 was a big one for regulatory. This was the last day that you could submit a major application just on paper. In its place is the new eCopy system just finalized by FDA in January. According to what we have been hearing from industry, many people are […]
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More Tips to Survive Your FDA Clinical Inspection
March 22, 2013 We sat down last week with Dennis Moore, the president of AUK Technical Services. Dennis was an FDA investigator for more than 15 years and has some interesting perspectives on FDA clinical inspections, to say the least! He also provided some great tips on regular FDA inspections. Make sure that you always […]
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FDA Recall Strategy Tips
March 25, 2013 We recently had the opportunity to chat with Rita Hoffman, who currently is the managing partner of RHoffman, Inc. She has more than 35 years of FDA experience in drugs, devices and veterinary products. Until 2010, she was the recall branch chief for CDRH. She gave us some useful FDA recall tips […]
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Danger! Beware of Legal Landmines in Your Company’s Records
March 21, 2013 If you ever wondered how a record in your pharmaceutical company can be a ‘landmine,’ Nancy Singer has the answer. She teaches an unusual, in person seminar called Dangerous Documents: Avoiding Land Mines in Your Emails and FDA Records. According to Singer, the term ‘land mine’ is a term for a possibly […]
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FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
March 24, 2013 Essential FDA Compliance Tips for Sr. Management When FDA arrives at your manufacturing plant, you might feel a twinge of panic. Or maybe you regret that you did not have time to solve some of the problems the FDAers may reveal. But, know that FDA inspection panic and regret is not something […]
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Hot Story – Yes or No – Should You Shut Down Production During an FDA Inspection?
March 18, 2013 – Updated March 20 Hot story of the week! Our recent Webinar speaker, Dennis Moore, AUK Technical Services, noted that while having your production system down during an inspection is not necessary, it can be useful in some situations. On the ‘no’ side, Moore noted that most 483 hits come on records […]
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5 Do’s and Don’ts for Your Next cGMP FDA Inspection
March 19, 2013 Hot Story – Avoid a CAPA File Inspection Disaster Our Webinar last week with Dennis Moore on cGMP FDA inspection tips, tricks, disasters and horror stories was really informative (and it’s rebooked for April 11). What I liked the most was his very simple point that FDA investigators are people too. If […]
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