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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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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