Data Integrity in the COVID-19 Era and Beyond
A Three-Part FDAnews/CenterWatch Virtual Conference Series

 

 

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.

  • Part I: The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic
    Tuesday, Aug. 4, 2020, 1:30 p.m. - 5:00 p.m. EDT

    1. 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”

    2. 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

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

  • 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.

Three-Part Series Pricing

Virtual Conference plus Recording & Transcript Bundle
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$1,096

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Virtual Conference only
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$646

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24/7 Encore plus Recording & Transcript Bundle
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$1,096

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24/7 Encore Presentation
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$646

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Virtual Conference Recording & Transcript Bundle
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$646

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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

 

Meet Your Facilitator

Sue Schniepp

Distinguished Fellow
Regulatory Compliance Associates

Sue Schniepp, distinguished fellow at Regulatory Compliance Associates, is a data integrity expert who has served on the board of directors of the Parenteral Drug Association, as the PDA/FDA Joint Regulatory Affairs conference chair, and as chair of the PDA’s Regulatory Affairs/Quality Advisory Board. She has also been a PDA conference presenter and was awarded PDA’s Distinguished Service Award.

Sue Schniepp will be joined by an array of data integrity experts, including policy advisors, regulatory compliance experts, and medical product consultants.