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/CenterWatch Virtual Conference Series

Tuesday, Aug. 4, 2020 • 1:30 p.m. - 5:00 p.m. EDT

 

COVID-19 has spread across the globe and in an effort to quell the pandemic, the FDA responded with guidelines to expedite effective treatments and devices. They’ve set new regulations meant to hasten the development and approval of products that could prevent, diagnose or treat the virus.

These guidelines, along with the Coronavirus Treatment Acceleration Program, Operation Warp Speed and growing public pressure, have rapidly pushed forward the process of finding solutions to this massive health crisis.

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

Concerned about how you can maintain 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 you’ve set for your team?

This three-part FDAnews virtual conference has your answers.

In the first portion, we’ll cover how the FDA’s new guidance impacts data integrity, ways medical product companies are conducting clinical trials during the current pandemic, and how data integrity might change permanently as a result of COVID-19 changes. We’ll also discuss techniques for managing inspections, audits, and supply chain concerns.

Data integrity expert Sue Schniepp will lead conversations and panels around data in the time of COVID-19. She and a group of experts will share tips and examples around altering operations, securing supply chains, and managing clinical trials in the time of a global pandemic. 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.

Key Virtual Conference Takeaways:

  • Data Integrity in the Age of COVID-19
    1. The impacts of COVID-19 on operations and supply chain management
    2. Conducting clinical trials during the pandemic
    3. Data practices that may become the “new normal”

  • FDA Regulations Around Data and COVID-19
    1. Guidance that most affects data integrity
    2. Regulations that may last beyond the pandemic
    3. Possible compliance issues in 2021

  • Inspections and Audits
    1. General changes in inspection and audit practices
    2. Virtual inspections and audits, including challenges and best practices

Click here to view the Part 1 agenda.

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

    1. Managing suppliers
    2. Mastering testing and validation requirements
    3. Dealing with digital transformations

  • Part III — The Real-World Costs of Data Integrity
    Wednesday, Oct. 28, 2020, 1:30 p.m. – 5:00 p.m. EDT

    1. Building a world-class data integrity program
    2. Creating record keeping and archival controls
    3. Using advanced tactics to cut costs and reduce workloads
    4. Deploying a risk management strategy for defensible data integrity

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

Join us by registering for this three-part series today.

Part I Pricing

 

 

Virtual Conference plus Recording & Transcript Bundle
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$487

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Virtual Conference only
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$287

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24/7 Encore plus Recording & Transcript Bundle
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$487

add to cart

24/7 Encore Presentation
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$287

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Virtual Conference Recording & Transcript Bundle
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$287

add to cart
Click here to view
the Part 1 agenda
Click here to view
the speakers bios
Register for the
Three-Part Series

 

Who Will Benefit

  • Pharmaceutical and device manufacturing teams
  • CROs and clinical trial sponsors
  • Data integrity consultants
  • Regulatory, quality, and compliance specialists
  • Clinical trial developers
  • Clinical study data experts
  • Vice presidents of strategic planning
  • Medical product attorneys
  • Drug and device consultants

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