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Core Requirements, Expectations and Challenges — March. 23 and March. 25, 2021

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WCG CenterWatch

WCG CenterWatch


FALLS CHURCH, Va. (PRWEB)

Data Integrity for GCP Professionals:

Core Requirements, Expectations and Challenges

A Virtual Workshop Presented by CenterWatch and Cerulean Associates LLC

Tuesday, March 23 and Thursday, March 25, 2021, 10:00 a.m.-4:30 p.m. EDT

https://www.centerwatch.com/dataintegrityforgcppros

Is the FDA’s increasing scrutiny on clinical trials’ data integrity producing a data migraine? One must establish internal competency and assessment programs; otherwise, one can expect 483s and warning letters 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 attendees can follow. A former FDA and Department of Justice prosecutor calls Mr. Avellanet, “The best in the business. Period.” Confirm this for yourself 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 a 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, March 23 and Thursday, March 25, 2021, 10:00 a.m.-4:30 p.m. EDT

https://www.centerwatch.com/dataintegrityforgcppros

Tuition:

$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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