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DAY 1 ✦ LIVE: Oct 28th - EDT
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DAY 1 ✦ LIVE: Oct 28th - EDT
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DAY 1 ✦ LIVE: Oct 28th 10:00am - 10:15am15 mins
Informa Connect-IVT and Chairperson’s Welcoming Remarks
- Katie Laquidara - Conference Producer, Informa Connect–IVT
- Connie Hetzler - Global Validation Head, Alcon Laboratories
DAY 1 ✦ LIVE: Oct 28th 10:15am - 11:00am45 mins
Implement A Risk-Based, Data Integrity Compliant Cleaning Validation Management System
- Susan Cleary - Director, Product Development, Novatek International
DAY 1 ✦ LIVE: Oct 28th 11:00am - 11:30am30 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
DAY 1 ✦ LIVE: Oct 28th 11:30am - 12:00pm30 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)
DAY 1 ✦ LIVE: Oct 28th 12:00pm - 1:30pm90 mins
TAKE TIME FOR NETWORKING VIRTUALLY AND VIEWING ON‑DEMAND CONTENT
DAY 1 ✦ LIVE: Oct 28th 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 SMALL GROUP ROUNDTABLE DISCUSSIONS
DAY 1 ✦ LIVE: Oct 28th 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
DAY 1 ✦ LIVE: Oct 28th 3:00pm - 3:45pm45 mins
IT, CSV AND DATA INTEGRITY
- Michael Gameng - Associate Director, GxP Enterprise Applications, MyoKardia
- Clark Davies, ASQ CSQE - Sr. Software Quality Engineer, Abbott Nutrition
- Atul Darji - Senior Manager, Quality Systems, Johnson & Johnson
DAY 1 ✦ LIVE: Oct 28th 3:00pm - 3:45pm45 mins
VERIFICATION AND VALIDATION FOR MEDICAL DEVICES
- Tim Carr - Sr. Quality Systems Engineer, Boston Scientific
DAY 1 ✦ LIVE: Oct 28th 4:00pm - 4:40pm40 mins
Risk-Based Approaches to Change Control in the Validated State
- Jefferey Jones - Executive Director, CMC Regulatory Affairs, Humacyte