DAY 1 ✦ LIVE: Oct 28th - EDT

10:30am - 10:45am15 mins

Informa Connect-IVT and Chairperson’s Welcoming Remarks

10:45am - 11:15am30 mins

MASTERING REGULATORY COMPLIANCE LIGHTNING KEYNOTE ● Updates on New and Emerging Regulations in the Pharmaceutical Space

Gopi Vudathala, PhD - Head, Global Regulatory Affairs CMC, Incyte Corporation

11:15am - 12:00pm45 mins

INSPECTION READINESS ● Evaluate Emerging Trends in Enforcement and Ensure Inspection Readiness

Libia Lugo - Drug Specialist, Division of Pharmaceutical Quality Operations Division 2 (DPQO Division 2), Office of Pharmaceutical Quality Operations (OPQO), Office of Medical Products and Tobacco Operations (OMPTO), U.S. Food and Drug Administration (USFDA)

12:00pm - 1:30pm90 mins

TAKE TIME FOR NETWORKING VIRTUALLY AND VIEWING ON‑DEMAND CONTENT

1:30pm - 2:30pm60 mins

4TH ANNUAL EMPOWERMENT, DIVERSITY AND INCLUSION SUMMIT ● Paving the Way for Progress in Validation

Kelly Simpliciano, MS - Associate Director, Audits & Inspections, Global Quality – Clinical Trials Systems & Auditing QA, Bristol Myers Squibb
Karen Ginsbury, MSc, BPharm, MRPharmS - President and CEO, PCI Pharmaceutical Consulting Israel
Connie Hetzler - Global Validation Head, Alcon Laboratories
Gopi Vudathala, PhD - Head, Global Regulatory Affairs CMC, Incyte Corporation

CHOOSE FROM THREE CONCURRENT LIVE SPEAKER Q+A WITH ON-DEMAND SESSION PRESENTERS

3:00pm - 3:45pm45 mins

PHARMACEUTICAL PROCESS VALIDATION

Jeff Hanson, CQE - Associate Director, Validation Engineering, Upsher-Smith Laboratories, LLC
Paul L. Pluta, PhD - Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance, Informa Connect
Jennifer Popovich - Director of Validation, Mayne Pharma, Inc

3:00pm - 3:45pm45 mins

IT, CSV AND DATA INTEGRITY

3:00pm - 3:45pm45 mins

VERIFICATION AND VALIDATION FOR MEDICAL DEVICES

4:00pm - 4:40pm40 mins

Risk-Based Approaches to Change Control in the Validated State