FDA data integrity requirements are among the most stringent within regulated industries, so compliance is quite the challenge. Unless you establish internal competency and assessment programs, you can expect to receive a Form 483 or warning letter.
It’s no surprise: the FDA continuously trains its investigators on how to conduct data integrity inspections. The result is inspectors who cite a significant number of data integrity observations during inspections, taking action against companies that commit data fraud or provide false information.
Making matters worse, investors and business partners are getting into the act: they’re filing multimillion-dollar class-action lawsuits against firms that misrepresented their compliance with FDA requirements.
Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges is an interactive virtual workshop that will give you the tools you need to ensure your electronic records are trustworthy and reliable across their entire data lifecycle, from initial data creation through long-term archives.
It will be led by award-winning FDA compliance expert, author and Cerulean Associates founder, John Avellanet. He 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 you can follow. A former FDA and Department of Justice prosecutor calls Mr. Avellanet, “The best in the business. Period.”
Virtual Workshop Takeaways:
No more data migraines. By attending this virtual workshop you’ll be equipped to help yourself, the team and the entire company stay compliant. Join us by registering today.
Cerulean Associates LLC
John Avellanet, founder of Cerulean Associates LLC, is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. He was the lead author of several certification courses on GMP and QSR supplier management for the U.S. Regulatory Affairs Professional Society. Mr. Avellanet has trained FDA investigators and district officers, and spent over 15 years being directly accountable for data integrity and regulatory compliance. During his career, he passed multiple regulatory inspections. He was personally trained by the authors of 21 CFR 11 to conduct FDA inspections.