Clinical Quality Oversight has ended

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Clinical Quality Oversight

8:00am EDT

Registration and Breakfast in Exhibit Area

8:30am EDT

WORKSHOP A: Quality Tolerance LimitsJonathan Rowe WORKSHOP B: Proactive Risk Management at Emerging CompaniesMichele Weitz

12:00pm EDT

Lunch for Workshop Participants

1:00pm EDT

WORKSHOP C: Clinical CAPA Flavors, Which is for You?Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP WORKSHOP D: Risk-Based Vendor Qualification

8:00am EDT

Registration and Breakfast in Exhibit Hall

8:30am EDT

Chairperson's Welcome and Industry UpdateDavid Fryrear

9:00am EDT

KEYNOTE ADDRESS: Trust Through TransparencyJonathan Taylor

9:30am EDT

SENIOR LEADERS PANEL: Quality Vs. Business NeedsSharon Reinhard, M.S. • Jessica Lee • David Fryrear • Priya Chaturvedi, Ph.D.

10:30am EDT

Networking and Refreshment Break

11:00am EDT

RISK-BASED AUDITING: Improving Resource Utilization and Issue DetectionJonathan Rowe

11:30am EDT

REGULATORY UPDATE: FDA InspectionsMiah Jung, Pharm.D., M.S.

12:15pm EDT

Lunch

1:00pm EDT

TRACK A: Critical To Quality FactorsMaria Weber • Patrice Benner TRACK B: Clinical Trial AnalyticsKathie Clark

1:30pm EDT

TRACK A: eTMF and eISF IntegrationRick Arlow • Aaron Grant TRACK B: Monitoring in a Decentralized WorldBrian Barnes

2:00pm EDT

Q&A With Previous Speakers

2:15pm EDT

Networking and Refreshment Break

2:45pm EDT

TRACK A PANEL: Remote QA Best PracticesMichael Torok, Ph.D. • MyLe Hoang • Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP • Lauren Hartman, RQAP-GCP

3:45pm EDT

ROUNDTABLE DISCUSSIONS

4:30pm EDT

BOOZE AND SCHMOOZE NETWORKING RECEPTION

8:30am EDT

Registration and Networking

9:00am EDT

TRACK A: Case Study of 100% Virtual COVID-19 Vaccine TrialMaryann Livolsi TRACK B: Risk Remediation Strategies for Regulatory InspectionsAaron Grant • Sarah Tucker

9:30am EDT

TRACK A: RBQM and Centralized Monitoring - Pfizer's COVID-19 Vaccine DevelopmentLynne Cesario • Steve Young TRACK B: RBQM and TMFLisa D. Mulcahy • Darshan Patel

10:00am EDT

Q&A With Previous Speakers

10:15am EDT

Networking and Refreshment Break

10:45am EDT

TRACK A PANEL: Documenting OversightEileen DiRita • Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP • Dawn Lundin • Michele Weitz

11:45am EDT

Lunch

12:45pm EDT

QUALITY MANAGEMENT SYSTEMAnthea Dransfield, BSc, MSc, CChem, MRSC • Dr. Steffen Engel

1:15pm EDT

TRAINING THE NEXT GENERATION OF QUALITY PROFESSIONALSSharon Reinhard, M.S.

1:45pm EDT

PANEL: GCP Inspection GossipMaryann Livolsi • Jonathan Taylor • Michele Weitz • Donna Dorozinsky

2:45pm EDT

CHAIRPERSON'S CLOSING REMARKSDavid Fryrear