Data Integrity in the COVID-19 Era and Beyond
Part II: Key Issues in Data Integrity:
Today and Tomorrow

A Three-Part FDAnews/CenterWatch Virtual Conference Series

Wednesday, Sept. 23, 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.

Do you know how to best use to data to manage your supply chain? Have you determined the ways technological advancements, like AI and blockchain, can improve your success? How will your team will adjust to this “new normal”?

This three-part FDAnews virtual conference has your answers.

In this second portion, we’ll cover how to manage your suppliers during and after this global pandemic. We’ll help you figure out the best ways to keep your suppliers on track and how to use technology to gain greater security in your systems. We’ll also discuss testing and validation requirements, AI and blockchain opportunities, and electronic submission obligations.

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 managing suppliers, meeting testing and validation requirements, and dealing with digital transformations around the pandemic. The group will examine what data integrity’s “new normal” may look like and share advice on how organizations can leverage technological developments to meeting changing global needs.

Key Virtual Conference Takeaways:

  • Managing Suppliers
    1. Keeping suppliers on track during a global pandemic
    2. Using technological developments to secure supply chains
    3. Dealing with problematic suppliers

  • Measuring Testing and Validation Requirements
    1. Ensuring testing and validation meets good manufacturing practices requirements
    2. Taking advantage of technological updates
    3. Adapting to the “new normal” after the pandemic

  • Dealing with Digital Transformation
    1. Making AI and blockchain work for you
    2. Complying with electronic submission requirements
    3. Preparing for post-pandemic digital obligations

Click here to view the Part II agenda.

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

  • Part I — The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic
    Purchase as an Encore Presentation. Recorded on Thursday, Aug. 4, 2020

    1. Data integrity and practices in the age of the COVID-19
    2. The impacts of COVID-19 on operations and supply chain management
    3. FDA regulations around data and COVID-19
    4. Inspection and audit practices, including virtual interactions and best practices

  • 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, manage your complicated supply chains, and make advances through technological changes.

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

Part II Pricing

 

 

Virtual Conference plus Recording & Transcript Bundle
Learn more

$487

add to cart

Virtual Conference only
Learn more

$287

add to cart

24/7 Encore plus Recording & Transcript Bundle
Learn more

$487

add to cart

24/7 Encore Presentation
Learn more

$287

add to cart

Virtual Conference Recording & Transcript Bundle
Learn more

$287

add to cart
Click here to view
the Part II 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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