FDAnews Announces — Data Integrity in the COVID-19 Era and Beyond Part I: The Impact of COVID-19, A Three-Part Virtual Conference Series Aug. 4, 2020

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Drug and devicemakers: Maintain data integrity while responding to the new, faster-paced research and manufacturing process.

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WCG FDAnews

Data Integrity in the COVID-19 Era and Beyond
Part I: The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic
A Three-Part FDAnews Virtual Conference Series
Tuesday, Aug. 4, 2020, 1:30 p.m. - 5:00 p.m. EDT
https://www.fdanews.com/part1diimpactcovid19

As the world battles the COVID-19 pandemic, the medical research and manufacturing community is working tirelessly to find solutions. Expectations of the industry to quell the crisis are rising, with the Coronavirus Treatment Acceleration Program, Operation Warp Speed and growing public pressure pushing for effective treatments and vaccines. To answer that need, the FDA has set new guidelines to expedite products that prevent, diagnose or treat the virus.

But this swift pace hasn’t absolved drug and device manufacturers and researchers of their long-held data integrity responsibilities. While the processes may be moving at a quicker pace, these standards remain the steadfast.

Concerned about maintaining the same essential data practices during these pressing times? Wondering how it’s possible to succeed in this fast-paced journey while sustaining the crucial standards of success set for your team?

This three-part FDAnews virtual conference has the answers.

Data integrity expert Sue Schniepp will lead conversations with other experts covering tips and examples around altering operations, securing supply chains, and managing clinical trials during the COVID-19 crisis. The group will also examine what data integrity’s “new normal” may look like and advice on how organizations can succeed through adjusted inspections and audits.

During Part I, we will cover:

  • Data Integrity in the Age of COVID-19

     a. The impacts of COVID-19 on operations and supply chain management
     b. Conducting clinical trials during the pandemic
     c. Data practices that may become the “new normal”

  • FDA Regulations Around Data and COVID-19

     a. Guidance that most affects data integrity
     b. Regulations that may last beyond the pandemic
     c. Possible compliance issues in 2021

  • Inspections and Audits

     a. General changes in inspection and audit practices
     b. Virtual inspections and audits, including challenges and best practices

Stay with us for the entire three-part virtual conference and we’ll cover:

  • Part II — Key Issues in Data Integrity: Today and Tomorrow

Wednesday, Sept. 23, 2020, 1:30 p.m. – 5:00 p.m. EDT

  • Part III —The Real-World Costs of Data Integrity

Wednesday, Oct. 28, 2020, 1:30 p.m. – 5:00 p.m.

Don’t let data integrity compliance issues jeopardize the effectiveness, safety, and success of one’s medical products. This virtual conference will give the tools needed to maintain this crucial element of the process, avoid new regulatory concerns, and manage COVID-19 data adjustments.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Data Integrity in the COVID-19 Era and Beyond
Part I: The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic
A Three-Part FDAnews Virtual Conference Series
Tuesday, Aug. 4, 2020, 1:30 p.m. - 5:00 p.m. EDT
https://www.fdanews.com/part1diimpactcovid19

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/part1diimpactcovid19
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
FDAnews
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