Can a clinical trials’ data integrity controls withstand FDA scrutiny? Stay compliant and avoid 483s or warning letters. Register today.
FALLS CHURCH, VA. (PRWEB) NOVEMBER 11, 2020
Data Integrity for GCP Professionals:
Core Requirements, Expectations and Challenges
A Virtual Workshop Presented by CenterWatch and Cerulean Associates LLC
Tuesday, Dec. 1 and Thursday, Dec. 3, 2020, 10:00 a.m.-4:30 p.m. EST
https://www.centerwatch.com/dataintegrityforgcpprosIs the FDA’s increasing scrutiny on clinical trials’ data integrity causing a data migraine? One must establish internal competency and assessment programs; otherwise, 483s and warning letters can be expected to come rolling in.
With FDA data integrity requirements among the most stringent within regulated industries, compliance is highly challenging. This interactive virtual workshop makes it infinitely easier.
Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges will give attendees the tools needed to ensure a clinical trials’ 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 for oneself when he shares:
How to apply the elements of data integrity characteristics — attributable, legible, contemporaneous, original and accurate (ALCOA+) — to real-world clinical development, trial conduct and post-trial analysis
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 deal with suppliers, including data integrity chain-of-custody in the clinical space, typical clinical supplier red flags that FDA and other regulatory health agencies look for and dealing with critical suppliers that collect, handle and store clinical digital data… but are not regulated
What, where, how and why to document data integrity controls and institute a risk-based approach, including monitoring data integrity controls with contract research organizations (CROs) and investigator sites
Considerations regarding emerging issues: long-term archival storage, cloud-based technologies, wearables data and patient-submitted digital data; plus, the impact of inspectional changes in the clinical arena
What one must know about GCP data integrity enforcement, using real-world examples and statistics from regulatory agencies and providing recent updates to FDA’s pre-approval inspection (PAI) methods
Takeaways regarding both on-site and remote clinical digital data inspections, with questions and tactics one must be prepared to handle
The risks of true and certified copies with digital records, from the basics of true/certified copy and legal admissibility, to true-copy requirements from submission guidances and putting together a true-copy scanning process for clinical trial usage
How to prepare for and handle GCP data integrity: address challenges with remote inspection handling, perform sponsor-specific and CRO-specific activities, points to remember when responding to allegations of untrustworthy data and more
No more data migraines. Avoid the data integrity Form 483s or warning letters while compliantly managing one’s clinical trials’ essential data.
Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.
Virtual Conference Details:
Data Integrity for GCP Professionals:
Core Requirements, Expectations and Challenges
A Virtual Workshop Presented by CenterWatch and Cerulean Associates LLC
Tuesday, Dec. 1 and Thursday, Dec. 3, 2020, 10:00 a.m.-4:30 p.m. EST
https://www.centerwatch.com/dataintegrityforgcpprosTuition:
$597
Easy Ways to Register:
Online: https://www.centerwatch.com/dataintegrityforgcppros
By phone: 888.838.5578 or 703.538.7600
About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.
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