Browsing Category Compliance Tips

Setting Up Your Bulletproof MDR File, and How to Avoid Landmines

More Exclusive cGMP FDA Compliance News May 2- Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 11, 2013 May 2- Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission As we noted in our earlier article, medical device firms usually have to report an MDR […]

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Category : Compliance Tips

Understanding the Medical Device Reporting Regulations

More Exclusive cGMP FDA Compliance News May 2- Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 11, 2013 Back in 2003, Endovascular Technologies, which made medical devices to treat some types of aortic aneurysms, pled guilty in federal district court to a shocking 10 felonies. The firm agreed to […]

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Category : Compliance Tips

Essential cGMP Quality Tips for Senior Managers

More Exclusive FDA and cGMP Compliance News According to a former FDA deputy chief counsel, senior managers and executives need to know and prevent non-compliance of cGMP regulations. As a senior manager for an FDA-regulated drug or device company, you are responsible for cGMP guidelines being followed in your company’s quality systems. You need to […]

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Category : Compliance Tips

Expert Recommendations for FDA eCopy Submission

April 10, 2013 Our April 10 Webinar on Avoiding the eCopy Confusion by Antoinette Azevedo had some vital expert recommendations. For instance Print to PDF is NOT an option with preparing PDFs for eSubmitter! This webinar really helped to shed some light on this very confusing and misunderstood guidance that became a requirement on Jan. […]

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Category : Compliance Tips

Pfizer Hit With Warning Letter For Serious cGMP Manufacturing Problems

More Exclusive FDA and cGMP News April 10, 2013 FDA sent a serious warning letter to an Italian Pfizer plant this week. According to the letter, Pfizer violated some very basic cGMP regulations. One of the most serious was with its testing of samples of batches of a certain diluting agent, which was for its […]

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Category : Compliance Tips &News

Does My FDA eCopy Submission Meet FDA Requirements?

April 9, 2013 We continue to see a lot of mass confusion and questions about FDA’s new eCopy initiative. We hope that our Webinar on FDA eCopy April 10 and May 2 will help registrants to better understand eCopy’s complex requirements. One of the most common questions we hear about eCopy is: How do we […]

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Category : Compliance Tips

eCTD Tips – Transitioning from Paper To Electronic Submissions

April 9, 2013 We find that the successful adoption of the eCTD format means that you need to have the proper strategic assimilation of the proper people and the proper technology. And FDA has been busy the last few years promoting the many virtues of submitting documents electronically. As of 2012, about 70% of new […]

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Category : Compliance Tips

How to Stay Compliant with 21 CFR Part 11

April 8, 2013 We all know we need to stay in compliance with all aspects of cGMP guidelines, but few FDA compliance subjects are more asked about than 21 CFR Part 11. According to some reports, the cost of complying with this FDA regulation can range from $5 million to more than $350 million, all […]

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Category : Compliance Tips

Kabco Pharma Consent Decree Lesson – Provide Complete Warning Letter Reponse to FDA

April 8, 2013 The hammer has fallen on Kabco Pharmaceuticals. Kabo must shut down all production of its dietary products until it can prove that its quality systems and facilities meet cGMP guidelines. The consent decree came after FDA filed the complaint against Kabco in July 2012. This was after a warning letter from 2010 […]

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Category : Compliance Tips

15 Simple Tips for cGMP-Compliant Quality Systems

Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 8, 2013 If you want to have cGMP-compliant quality systems in your pharmaceutical operation, here are some easy tips to remember: SOPS Create a flowchart or process map before you start to assemble the language of the SOP. Try to write […]

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Category : Compliance Tips

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