Part II Agenda
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| 1:30 p.m. - 1:35 p.m. |
Welcoming Remarks
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
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| 1:35 p.m. - 2:00 p.m.
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Keynote Address: Why Data Integrity Is More Than Just a Regulatory Burden
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health
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2:00 p.m. - 2:45 p.m.
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Managing Your Suppliers
- How to Keep Your Suppliers on Track During the Pandemic
- How To Take Advantage of the Latest Technological Developments for Securing the Supply Chain
- How To Deal with Problematic Suppliers During the Pandemic
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelists:
David Elder, Executive Vice President, Regulatory Compliance, Greenleaf Health
Steve Lynn, Principal Consultant/Owner, Lynn Consulting
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health |
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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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Measuring Testing and Validation Requirements
- How to Ensure Testing and validation commitments meet GMP requirements
- How To Take Advantage of the Latest Technological Developments
- How to Adapt to the New Normal on Testing and Validation Post-Pandemic
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelist:
Deborah Fizz, Principal Consultant & Project Manager, Validation Services, LLC
Richard F. Lindauer, Principal, Lindauer Analytichem, LLC
Steve Lynn, Principal Consultant/Owner, Lynn Consulting |
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3:45 p.m. - 4:30 p.m.
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Dealing with Digital Transformation
- How to Take Advantage of AI and Blockchain
- How to Comply with Electronic Submission
- How to Prepare for a Post-Pandemic World
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelist:
Michael J. Gregor, President and CEO, Compliance Gurus
Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance Associates, Inc. |
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4:30 p.m. - 5:00 p.m.
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Unanswered Questions
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelist:
David Elder, Executive Vice President, Regulatory Compliance, Greenleaf Health
Deborah Fizz, Principal Consultant & Project Manager, Validation Services, LLC
Richard F. Lindauer, Principal, Lindauer Analytichem, LLC
Steve Lynn, Principal Consultant/Owner, Lynn Consulting
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health
Michael J. Gregor, President and CEO, Compliance Gurus
Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance Associates, Inc. |
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| 5:00 p.m.
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Adjournment |
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