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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Choppy Road Ahead for Confusing eCopy Initiative
Avoid Problems with CDRH eCopy March 19, 2013 On Jan. 1, 2013, the new FDA guidance titled ‘eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff” went into effect. This guidance provides us with instructions on how to do medical device submissions to the agency with eCopy. If you […]
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Facebook Frisking Your FDA Auditor; Why You Should Shut Down Production During 483 Inspection
March 18, 2013 Â The $100,000 FDA Compliance Disaster FDA Auditors Use Facebook, Too Audit Tip #1 – Facebook Search! In our Webinar with Dennis Moore last week, he provided some extremely insightful and colorful commentary on things you should and shouldn’t do in your next FDA inspection. One I particularly liked was why […]
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Like Candy at Easter – FDA Hands Out CAPA 483 Observations
Latest FDA and cGMP Compliance News Avoid a CAPA Inspection Disaster With a Closed Loop, FDA Compliant CAPA System, and Learn 7 Powerful Tools for Root Cause Analysis In the recent past, it seems that FDA has thought that if it focused a great deal on CAPA, it would solve many of the problems in […]
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Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, As Well
March 18, 2013 You probably know by now that CDRH now requires eCopy for most submissions since Jan. 1, 2013. Our electronics submissions expert, Antoinette Azevedo, has been informing us of some of the chaos that surrounds the new requirement both in the industry and at FDA (see our post on eCopy last week). As […]
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Tip – Check Out Your Vendor Quality Before Signing the Deal
March 15, 2013 It’s very important to check out your dance partner before you go to town with him or her, according to our business associate and quality agreement expert Alan Minsk, Arnall Golden Gregory LLP. And if you are a pharmaceutical company that is going to enter into a deal with a contract manufacturer, […]
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Why You Have to Have a Quality Agreement With Your Contractor
March 15, 2013 It’s incredibly important to have a quality agreement with any of your contract manufacturers. FDA can ask during an audit to take a look at any documents that describe how any contract service providers at your firm are managed. Also, any changes that are made to the product without approval from the […]
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