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VIRTUAL WORKSHOP

Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

Tuesday, Dec. 8, 2020 and Thursday, Dec. 10, 2020 • 10:00 a.m. - 4:30 p.m. EST | Presented by FDAnews and Cerulean Associates LLC

Is the FDA’s increasing scrutiny on data integrity giving you a data migraine?

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:

  • How to apply the elements of data integrity characteristics — attributable, legible, contemporaneous, original and accurate (ALCOA+)
  • An exploration of overlooked guidance documents that can help define expectations (including what the FDA and the European Medicines Agency inspect for and why)
  • How to address recall handling and reporting and product complaint trending
  • How to deal with suppliers, including the typical supply chain red flags that FDA and other regulatory health agencies look for
  • What to take away from recent, relevant GMP and QSR data integrity enforcement examples
  • Considerations for both on-site and remote inspections, with questions and tactics you must be prepared to handle
  • The modern, risk-based validation techniques you need to know, along with the FDA’s view of sampling, test cases and supplier-provided validations
  • The record-keeping “musts” to consider: which records to retain to prove good data integrity controls, incorporating quality audits and sampling techniques and developing a media migration strategy
  • The risks and realities of true and certified copies with digital records, from the basics of true/certified copy and legal admissibility to putting together a scanning process for manufacturing records and the true copy requirements from submission guidances

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.

 

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Who Will Benefit

  • Regulatory, Quality and Compliance Specialists
  • Vice Presidents, Strategic Planning
  • Medical Product Attorneys
  • Drug and Device Consultants

Meet Your Presenter

Dan O

John Avellanet

Founder

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.

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