Data Integrity in the COVID-19 Era and Beyond — Part III: The Real-World Costs of Data Integrity – Virtual Conference Recording/Transcript
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 what practices are best to create, maintain and archive your data? Is your team using data integrity concepts to increase productivity? How has your organization been using its risk management strategies when it comes to data?
This three-part FDAnews virtual conference has your answers.
This third session will cover best practices for the creation, maintenance and archiving of data and documents. It will help you increase productivity through effective data integrity practices and pull out the lessons COVID-19 is teaching us regarding data. You’ll learn how to apply ICH Q9 guidance, effective risk-management strategies and audit trails to approach data integrity 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 data processes that will prepare you for inspection compliance and ensure your team is following best practices regarding data. The group will examine the unique risk mitigation steps that you can take to support the integrity of your data systems and answer your questions on this essential topic.
Key Virtual Conference Takeaways:
- 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
- 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
- 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
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
- Data integrity and practices in the age of the COVID-19
- The impacts of COVID-19 on operations and supply chain management
- FDA regulations around data and COVID-19
- Inspection and audit practices, including virtual interactions and best practices
- 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
Data integrity compliance issues should never jeopardize the effectiveness, safety, and success of your medical products. Get the tools you need to maintain this key element of your process, determine which data integrity concepts best apply to your organization, and develop a meaningful risk management strategy for your team.
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
Virtual Conference Recording & Transcript Bundle
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Virtual Conference date:
Oct. 28, 2020