Print Agenda: FDA Inspections vSummit

Wednesday, November 8, 2023
10:00 AM - 10:15 AM	Welcome Plenary
10:00 AM - 4:00 PM	FDA Inspections vSummit Livestream Day 1 (Plenary and Drugs & Biologics Track)
10:15 AM - 10:45 AM	Keynote – Postpandemic Inspections: The New Normal Plenary
10:45 AM - 11:30 AM	Panel – FDA Inspectional Oversight Post-Pandemic: Challenges and Opportunities Plenary
11:30 AM - 11:45 AM	BREAK
11:45 AM - 12:30 PM	Device – FDA’s New QMSR – Updating 21 CFR 820 to Harmonize with ISO 13485:2016 Medical Devices	Drug – Thoughts from an ex-FDA Drug National Expert on Inspection Readiness & Drug GMP Compliance Drugs & Biologics
11:45 AM - 2:00 PM	FDA Inspections vSummit Livestream Day 1 (Medical Devices Track)
12:30 PM - 1:15 PM	LUNCH
1:15 PM - 2:00 PM	Drug – What a Drugmaker Needs to Know About CAPA Drugs & Biologics	Device – Defending Machine Learning in Inspections Medical Devices
2:00 PM - 2:45 PM	Panel – Don’t Get Ready, Be Ready: Inspection Readiness Is a State of Mind Plenary
2:45 PM - 3:00 PM	BREAK
3:00 PM - 3:45 PM	Plenary – Remote Assessments: What Does It Mean? Where’s the Authority? Plenary
3:45 PM - 4:00 PM	Closing Remarks Plenary
Thursday, November 9, 2023
10:00 AM - 10:15 AM	Welcome Plenary
10:00 AM - 4:00 PM	FDA Inspections vSummit Livestream Day 2 (Plenary and Drugs & Biologics Track)
10:15 AM - 11:00 AM	Plenary – Managing Data and Documentation for On-Site and Remote Inspections Plenary
11:00 AM - 11:45 AM	Will Your Vendors/Suppliers Pass FDA Inspection? Understanding Oversight Responsibility Plenary
11:45 AM - 12:00 PM	BREAK
12:00 PM - 12:45 PM	Drug – Will Your Risk Management Program Pass Inspection? Drugs & Biologics	Device – CAPA Is Not a Four-Letter Word: Streamlining the Process Medical Devices
12:00 PM - 1:00 PM	FDA Inspections vSummit Livestream Day 2 (Medical Devices Track)
12:45 PM - 1:30 PM	LUNCH
1:30 PM - 2:15 PM	Plenary – Mock Investigator Interview Plenary
2:15 PM - 3:00 PM	Panel – Do This, Not That Plenary
3:00 PM - 3:30 PM	Murphy’s Law of Inspections: If It Can Go Wrong, It Probably Will Plenary
3:30 PM - 4:00 PM	Adjourn Summit Plenary

Time Zone: (UTC-04:00) Eastern Time (US & Canada) []

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FDA Inspections vSummit Agenda