FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

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FDA investigators continue to cite a significant number of data integrity observations during inspections… with FDA taking action against companies that commit data fraud — or provide false information.

FDA data integrity requirements are among the most strenuous that regulated industries have to comply with.

And the FDA is keeping pressure on those with data integrity shortcomings — issuing a growing number of warning letters and FDA-483s every year for the last few years. In late 2017 came news that FDA was training its device investigators on how to conduct data integrity inspections.

Investors and business partners are getting into the act, filing multi-million-dollar class-action lawsuits against firms that misrepresented their compliance with FDA requirements. The latest lawsuits against Dr. Reddy’s just add to the list against KV Pharma and other firms.

Your electronic records must be trustworthy and reliable across their entire data lifecycle — from initial data creation all the way through long-term archival.

Compliantly managing your business' essential data can be an overwhelming, even mind-boggling undertaking.

Thankfully, there's an expert with deep knowledge who can explain complex FDA data integrity regulations in simple 'what to do, how to do it' language using real-world examples and offering practical advice.

And that's why you must plan NOW to attend this upcoming interactive workshop presented by FDAnews and Cerulean Associates LLC, a leading consulting firm.

Award-winning FDA compliance expert, author and Cerulean founder John Avellanet will be your workshop leader. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.

A former FDA and DOJ prosecutor calls Mr. Avellanet, “The best in the business. Period.”

After two days of 'total immersion' study, you'll return to your office with increased understanding based on team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with John and your fellow attendees.

During each of 10 workshop sessions, you'll participate in interactive group projects… review case studies … draft practice business cases, plans and communications … and more.

You'll also simulate investigative scenarios using real data from real inspections — and even determine whether or not warning letters should be issued!

Review the full detailed two-day agenda.

Consider this. The FDA gives simple instructions to its investigators: “If initial findings indicate the firm’s electronic records may not be trustworthy and reliable … a more detailed evaluation may be warranted.”

That's the polite way of saying this is when you can expect to receive a warning letter.

Don't let things get to the point of a warning letter. Attend FDA Data Integrity for Device and Pharma Firms, and Their Suppliers.

It's the right thing to do — for your company and for yourself.

 


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