Data Integrity in the COVID-19 Era and Beyond — Part I: The Impact of COVID-19 – Virtual Conference Recording/Transcript
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
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
- The impacts of COVID-19 on operations and supply chain management
- Conducting clinical trials during the pandemic
- Data practices that may become the “new normal”
- FDA Regulations Around Data and COVID-19
- Guidance that most affects data integrity
- Regulations that may last beyond the pandemic
- Possible compliance issues in 2021
- Inspections and Audits
- General changes in inspection and audit practices
- 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
Purchase as an Encore Presentation. Recorded Wednesday, Sept. 23, 2020.
- Managing Suppliers
- Keeping suppliers on track during a global pandemic
- Using technological developments to secure supply chains
- Dealing with problematic suppliers
- Measuring Testing and Validation Requirements
- Ensuring testing and validation meets good manufacturing practices requirements
- Taking advantage of technological updates
- Adapting to the “new normal” after the pandemic
- Dealing with Digital Transformation
- Making AI and blockchain work for you
- Complying with electronic submission requirements
- Preparing for post-pandemic digital obligations
- Part III — The Real-World Costs of Data Integrity
Wednesday, Oct. 28, 2020, 1:30 p.m. – 5:00 p.m. EDT
- Document and Data Creation, Maintenance and Archival: Best Practices
- Creating the data and documents you need to better obtain information for inspection compliance
- Maintaining and preserving documents through the latest technology
- Ensuring the deployment of industry best practices in inspection compliance
- Increasing Productivity through Effective Implementation of Data Integrity Concepts
- Determining which key data integrity concepts will best serve your organization
- Understanding how data integrity adherence can benefit both compliance and productivity
- Finding the lessons COVID-19 is teaching us about data integrity
- Deploying a Solid Risk Management Strategy for Data Integrity
- Applying the ICH Q9 guidance when implementing an effective risk management strategy around data integrity
- Making sure your team has meaningful and effective risk management strategies based on the design, operation and monitoring of systems and controls, along with the risk to patients, process and product
- Finding the unique risk mitigation strategies your team can employ to ensure the integrity of electronic data systems
- Using audit trails as part of a risk management strategy
- Remediating data integrity problems through a risk management strategy
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.
Meet Your Facilitator:
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.
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