15TH ANNUAL
FDA INSPECTIONS vSUMMIT
Tuesday, Nov. 17 – Wednesday, Nov. 18, 2020
#1 Event for Quality, Compliance and Regulatory Professionals
Handouts
Presentations
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Day 1 • 11:15 AM EST • General Session
Keynote Address: The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2021
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Day 1 • 12:15 PM EST • Drugs & Biologics
Be Ready for the FDA Drug GMP Facility Evaluations & Inspections During the Pandemic
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Day 1 • 12:15 PM EST • Medical Devices
CDRH Quality Pilot — Implementation of Capability Maturity Model
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Day 1 • 12:15 AM EST • Clinical Trials
How COVID-19 Has Taught Us to Streamline & Simplify Clinical Trial Processes
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Day 1 • 1:45 PM EST • Clinical Trials
Obtaining & Documenting Informed Consent When the Patient Is Not in the Room
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Day 1 • 2:30 PM EST • General Session
What’s a Regulatory Meeting and How Do You Prepare for It?
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Day 2 • 11:15 AM EST • General Session
Do’s and Don’ts for FDA Inspections: Analysis from Former FDA Investigators
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Day 2 • 12:15 PM EST • Medical Devices
Managing Virtual MDSAP Inspections
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Day 2 • 1:45 PM EST • Drugs & Biologics
Inspection Compliance — What’s Happening Now and What to Expect in 2021
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Day 2 • 1:45 PM EST • Medical Devices
Managing Medical Device Recalls
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Day 2 • 1:45 PM EST • Clinical Trials
Meeting CRO Vendor Oversight Requirements
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