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DAY 1 ✦ LIVE: Oct 28thkeyboard_arrow_right

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
    NextDAY 2 ✦ LIVE: Oct 29th
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