FDAnews Announces — Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges Virtual Workshop March 30, April 1, 2021

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Can one’s data integrity controls withstand FDA scrutiny? Here’s how to stay compliant and avoid 483s or warning letters. Register today.



Is the FDA’s increasing scrutiny on data integrity producing a data migraine? One must establish internal competency and assessment programs; otherwise, one can expect to receive a Form 483 or warning letter.

With FDA data integrity requirements among the most stringent within regulated industries, compliance is challenging for drug and device manufacturers. This interactive virtual workshop makes it infinitely easier.

Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges will give attendees the tools needed to ensure 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.” Confirm this when he shares:

  • 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 one must be prepared to handle
  • The modern, risk-based validation techniques needed 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. Attend this virtual workshop and become equipped to help the team and the entire company stay compliant.

Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.

Virtual Workshop Details:
Data Integrity for GMP/Postmarket Professionals:
Core Requirements, Expectations and Challenges
A Virtual Workshop Presented FDAnews and Cerulean Associates LLC
Tuesday, March 30 and Thursday, April 1, 2021, 10:00 a.m.-4:30 p.m. EDT


Easy Ways to Register:
Online: https://www.fdanews.com/dataintegrityforgmppmpros
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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