Complete Agenda

Start Time Name Track
Wednesday, November 16, 2022
12:00 PMRegistration 
1:00 PMInspection Readiness Metrics Workshop: How Do You Measure and Assess Inspection Readiness?Clinical Trials
1:00 PMEffective FDA Inspection Handling and 483 ResponseDrugs & Biologics
1:00 PMWelcome Back from COVID: Preparing for and Managing an FDA InspectionMedical Devices
5:00 PMPre-Conference Workshops Adjourn 
Thursday, November 17, 2022
8:00 AMRegistration & Continental Breakfast 
9:00 AMWelcoming RemarksPlenary
9:15 AMKeynote Address — The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2023Plenary
10:00 AMAuditing Manufacturers: Linking Data Integrity with Quality CulturePlenary
10:45 AMRefreshment and Networking Break 
11:00 AMPurpose Driven Inspection Preparedness: People, Process and Technology — Critical Components to SuccessClinical Trials
11:00 AMHow to Ensure Your Drug or Biologics Manufacturing Facility Is Ready to be Evaluated by the FDA Either Remotely or In-PersonDrugs & Biologics
11:00 AMCybersecurity: The Current Regulatory Landscape and How to Defend Your Practices During an InspectionMedical Devices
12:30 PMLuncheon 
1:30 PMThe Potential — and Limitations — of Technology-Driven TMF ComplianceClinical Trials
1:30 PMThe Impact of AI and New TechnologyDrugs & Biologics
1:30 PMThe Impact of AI and New Technology on Regulatory ComplianceMedical Devices
2:30 PMRefreshment and Networking Break 
2:45 PMBIMO in Action: AQC Members Share Insights from Their Recent Inspection ExperiencesClinical Trials
2:45 PMLessons Learned from COVID-19 & Supply Chain Mayhem Drugs & Biologics
2:45 PMFDA’s Shift from QSR to ISO 13485:2016: A Significant Change for InspectionsMedical Devices
3:30 PMRefreshment and Networking Break 
3:45 PMValidating Your Systems and Equipment for CompliancePlenary
4:30 PMMock Inspection: Practice Makes PerfectPlenary
5:30 PMNetworking Reception 
Friday, November 18, 2022
8:00 AMRegistration & Continental Breakfast 
9:00 AMOpening Comments by Committee ChairPlenary
9:15 AMCommunicating with the FDA: How to Facilitate an Inspection Post-COVID Plenary
10:00 AMOrganizing Data and Document Archives: Finding a Needle in a Haystack for FDA InspectionsPlenary
10:45 AMRefreshment and Networking Break 
11:00 AMPanel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on SitePlenary
12:00 PMSummit Adjourns