April 13 - 15, 2021
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LIVE ✦ CONTENT - EST
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*All times are EST
LIVE ✦ CONTENT 10:00am - 10:30am30 mins
DAY 3 ● Thu, Apr 15th
RISE AND SHINE YOGA
LIVE ✦ CONTENT 10:30am - 10:45am15 mins
DAY 1 ● Tue, Apr 13th
Informa Connect’s Welcome and Co-Chairs’ Opening Remarks
- Elise Wyatt - Conference Producer, Informa Connect
- Ken Shitamoto, MS - Senior Director, IT, Gilead Sciences
- Senthil Gurumoorthi - Associate Director, Gilead Sciences
LIVE ✦ CONTENT 10:30am - 10:45am15 mins
DAY 2 ● Wed, Apr 14th
Day Two Kick-Off
- Ken Shitamoto, MS - Senior Director, IT, Gilead Sciences
LIVE ✦ CONTENT 10:30am - 10:45am15 mins
DAY 3 ● Thu, Apr 15th
Day Three Kick-Off
- Senthil Gurumoorthi - Associate Director, Gilead Sciences
LIVE ✦ CONTENT 10:50am - 11:50am60 mins
DAY 1 ● Tue, Apr 13th
PANEL DISCUSSION ● Excellence and Next Generation Approaches to Quality System Monitoring and Analysis — Perspectives in Innovation
- Michelle Miller - Director, Global Validation, Illumina
- Daniel Caparrós - Head of Global Quality Strategy Data and Vendor Management, Merck KGaA, Darmstadt, Germany
- Nuala Calnan, PhD - CEO; Founder, BioPharm Excel Ltd; The Quality Risk Management Institute (QRMi)
- Alyce Deegan, MBA, PMP, CQA - Director, CSV, Seagen
LIVE ✦ CONTENT 10:50am - 11:50am60 mins
DAY 2 ● Wed, Apr 14th
The Digital Transformation
- Daniel Matlis - President, Axendia
- Paul Hurlocker - VP, Platform Solutions & Engineering – Center for Machine Learning, Capital One
- Sam Cheemakoti - GMP Head, IT Systems for OTC Drugs, Beiersdorf
- Ron Schardong - Senior Director, Technology Quality – CSV, Johnson & Johnson
LIVE ✦ CONTENT 10:50am - 11:35am45 mins
DAY 3 ● Thu, Apr 15th
Cloud Computing Validation — Lessons Learned from the Front-Lines
- Ferdi Steinmann - Senior Global Industry Strategist, Life Sciences, OpenText
- Joanne Goldberg - Senior Principal IT Business Systems Analyst, Medtronic
- Scott Lundstrom - Senior Industry Strategist, Healthcare, OpenText
- Ron Schardong - Senior Director, Technology Quality – CSV, Johnson & Johnson
LIVE ✦ CONTENT 11:35am - 11:45am10 mins
DAY 3 ● Thu, Apr 15th
TAKE TIME TO STRETCH AND VIEW ON‑DEMAND DIVERSITY AND INCLUSION PODCASTS
LIVE ✦ CONTENT 11:45am - 12:30pm45 mins
DAY 3 ● Thu, Apr 15th
Analyze and Diagnose Risks from SaaS Vendor Audit Findings and Insights
- Holly Baldwin - Manager, Quality Validation CSV, Sanofi
LIVE ✦ CONTENT 11:50am - 12:00pm10 mins
DAY 1 ● Tue, Apr 13th
TAKE TIME TO STRETCH
LIVE ✦ CONTENT 12:00pm - 12:50pm50 mins
DAY 1 ● Tue, Apr 13th
PANEL DISCUSSION ● The CSA Revolution
- Ken Shitamoto, MS - Senior Director, IT, Gilead Sciences
- Senthil Gurumoorthi - Associate Director, Gilead Sciences
- Ray Murphy - Principal Software Quality Engineer, Boston Scientific
- Khaled Moussally - Executive Vice President, Clients & Regulatory Relations, Compliance Group
- Francisco Vicenty - Program Manager – Case for Quality, FDA
LIVE ✦ CONTENT 12:00pm - 12:45pm45 mins
DAY 2 ● Wed, Apr 14th
Evaluate and Assess Computer Validation Audits
- Leslie Lighton-Humphreys - IT SQA & CSV Manager, AmerisourceBergen
LIVE ✦ CONTENT 12:30pm - 1:25pm55 mins
DAY 3 ● Thu, Apr 15th
TAKE TIME FOR VIRTUAL NETWORKING WITH COLLEAGUES AND VIEW ON‑DEMAND CONTENT
LIVE ✦ CONTENT 12:45pm - 1:45pm60 mins
DAY 2 ● Wed, Apr 14th
TAKE TIME FOR VIRTUAL NETWORKING WITH COLLEAGUES AND VIEW ON‑DEMAND CONTENT
LIVE ✦ CONTENT 1:00pm - 1:30pm30 mins
DAY 1 ● Tue, Apr 13th
The Future is Coming — Software Validation Automation
- Ido Raz - CEO, Validify
LIVE ✦ CONTENT 1:25pm - 1:30pm5 mins
DAY 3 ● Thu, Apr 15th
Content Highlight presented by Kneat Solutions
LIVE ✦ CONTENT 1:30pm - 2:10pm40 mins
DAY 1 ● Tue, Apr 13th
TAKE TIME FOR VIRTUAL NETWORKING WITH COLLEAGUES AND VIEW ON‑DEMAND CONTENT
LIVE ✦ CONTENT 1:30pm - 2:15pm45 mins
DAY 3 ● Thu, Apr 15th
Evaluating the Intersection of QA and IT
- Joanne Goldberg - Senior Principal IT Business Systems Analyst, Medtronic
LIVE ✦ CONTENT 1:45pm - 2:15pm30 mins
DAY 2 ● Wed, Apr 14th
Minimize Audit Risk & Submission Timelines with Managed Hosting & Validation
- Ali Dootson - Director of Consulting, d-wise
- Phil Loucks - Client Manager, d-wise
LIVE ✦ CONTENT 2:10pm - 2:15pm5 mins
DAY 1 ● Tue, Apr 13th
Content Highlight presented by Kneat Solutions
LIVE ✦ CONTENT 2:15pm - 3:00pm45 mins
DAY 1 ● Tue, Apr 13th
Quality Agreements for Computer SaaS
- Geetanjali Abbi - Associate Director, Validation, Alkermes
LIVE ✦ CONTENT 2:15pm - 2:25pm10 mins
DAY 2 ● Wed, Apr 14th
TAKE TIME TO STRETCH
LIVE ✦ CONTENT 2:15pm - 2:25pm10 mins
DAY 3 ● Thu, Apr 15th
NETWORKING AND HYDRATION BREAK
LIVE ✦ CONTENT 2:25pm - 2:55pm30 mins
DAY 2 ● Wed, Apr 14th
Still Doing CSV? It's 2021! CSA - System Operation and Maintenance
- Khaled Moussally - Executive Vice President, Clients & Regulatory Relations, Compliance Group
- Harsha Chulki - Head of Global IT Quality, Compliance & CSV, ICU Medical Inc.
- Stephen Cook - VP, Quality and Compliance, Compliance Group
LIVE ✦ CONTENT 2:25pm - 3:10pm45 mins
DAY 3 ● Thu, Apr 15th
Ensuring Data Integrity in Virtual Environments
- Chris Wubbolt - Principal, QACV Consulting
LIVE ✦ CONTENT 3:05pm - 3:50pm45 mins
DAY 2 ● Wed, Apr 14th
How Much Validation is Enough?
- Raechelle Raimondo - Formerly Executive Director, Global IT Systems Assurance and Compliance, Allergan
- Pritam Khade - Director, Global Quality Compliance, Allergan Inc
- Shana Kinney - Associate Director, Validation, REGENXBIO
LIVE ✦ CONTENT 3:10pm - 3:55pm45 mins
DAY 1 ● Tue, Apr 13th
Risk-Based Approaches to CSA
- Sara Levy - CSV and Data Integrity Manager, Pluristem Therapeutics
LIVE ✦ CONTENT 3:15pm - 3:20pm5 mins
DAY 3 ● Thu, Apr 15th
Closing Remarks
- Elise Wyatt - Conference Producer, Informa Connect
LIVE ✦ CONTENT 3:50pm - 4:20pm30 mins
DAY 2 ● Wed, Apr 14th
TAKE TIME FOR VIRTUAL NETWORKING WITH COLLEAGUES AND VIEW ON‑DEMAND DIVERSITY AND INCLUSION PODCASTS