Part III Agenda
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| 1:30 p.m. - 1:40 p.m. |
Welcoming Remarks
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates Regulatory Compliance Associates
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| 1:40 p.m. - 2:00 p.m.
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Keynote Address: Top Takeaways from Parts I and II & a Look Ahead
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates Regulatory Compliance Associates
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2:00 p.m. - 2:45 p.m.
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Document & Data Creation, Maintenance & Archival: Best Practices
- How to create data and documents that enable you to obtain the information you need for inspection compliance
- How to maintain and preserve documents using the latest technology
- How to ensure that you’re deploying the best industry practices in inspection compliance
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates Regulatory Compliance Associates
Panelists:
Steve Lynn, Principal Consultant/Owner, Lynn Consulting, LLC
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC
Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance |
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| 2:45 p.m. - 3:00 p.m.
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Break |
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| 3:00 p.m. - 3:45 p.m.
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Increasing Productivity through Effective Implementation of Data Integrity Concepts
- What key data integrity concepts your organization should be adopting
- Why data integrity adherence can be good for both compliance and an effective productivity tool
- What lesion COVID-19 is teaching us about data integrity
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates Regulatory Compliance Associates
Panelist:
Steve Lynn, Principal Consultant/Owner, Lynn Consulting, LLC
Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance
Kalah Auchinloss, Senior Vice President, Regulatory Compliance, and Deputy General Counsel, Greenleaf Health |
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3:45 p.m. - 4:30 p.m.
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Deploying a Super Solid Risk Management Strategy for Data Integrity
- How to apply the guidance from ICH Q9 in implementing an effective risk management strategy for data integrity
- How to ensure you have meaningful and effective risk management strategies that are based on strategies considering the design, operation, and monitoring of systems and controls and are based on risk to patient, process, and product
- What unique risk mitigations strategies must be employed to ensure the integrity of electronic data systems?
- How do you effectively use audit trails as part of your risk management strategy?
- How do you remediate a data integrity problem using a risk management strategy?
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates Regulatory Compliance Associates
Panelist:
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC |
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4:30 p.m. - 4:45 p.m.
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Unanswered Questions
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates Regulatory Compliance Associates
Panelist:
Steve Lynn, Principal Consultant/Owner, Lynn Consulting, LLC
Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance
Kalah Auchinloss, Senior Vice President, Regulatory Compliance, and Deputy General Counsel, Greenleaf Health
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC |
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| 4:45 p.m.
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Adjournment |
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