AGENDA
11:00AM - 12:00PM
Registration - Coffee & Tea
12:00 - 12:15 PM
Chairperson's Opening Remarks
12:00 - 1:00 PM
Rethinking Your Approach to Technology - Implications of and Opportunities in CSA, Digitalization, Generative AI, and Machine Learning
Moderator: Madhavi Ganesan, Life Sciences Solution Director KPMG Panelists: Rosalind Beasley, CEO Main and Mission, Inc. Sachin Bhandari, Head of CSV and Qualification Standards Boehringer Ingelheim International GmbH Harsha Chulki, Head of Global IT Quality & Compliance ICU Medical Ray Murphy, Software Quality Engineering Fellow Boston Scientific
1:00 - 2:00 PM
Validating Pharma 4.0
Chinmoy Roy, Life Science Digital Transformation Consultant ValGenesis
2:00 - 3:00 PM
Emerging Technology and Services for Lean Validation Specialists in 2024
3:00 - 3:40 PM
Using Generative AI Solutions to Validate Systems
Madhavi Ganesan, Life Sciences Solution Director KPMG
3:40 - 4:20 PM
Harmonizing Equipment Qualification – Modular CSA Approach
Moderator: Khaled Moussally, Executive Vice President, Corporate Development & Operations, Compliance Group Panelists: Margaret Hindley PhD, CQA, CQE, Director CSA/IT Taiho Oncology Ray Murphy, Software Quality Engineering Fellow Boston Scientific Katelyn Staub-Zamperini, Senior Operations Officer ORA, FDA
4:20 - 5:10 PM
Harmonizing Equipment Qualification – Modular CSA Approach
Sachin Bhandari, Head of CSV and Qualification Standards Boehringer Ingelheim International GmbH
5:10 PM
Networking Cocktail Reception
7:30 - 8:20 AM
Exhibitor Showroom Opens and Lite Breakfast
8:20 - 9:20 AM
Select Between Knowledge Exchange Sessions
8:20 - 9:20 AM
Using AI to Enhance Your Validation Processes
Rosalind Beasley, CEO Main and Mission, Inc.
8:20 - 9:20 AM
Case Study: Implementing CSA
Margaret Hindley PhD, CQA, CQE, Director CSA/IT Taiho Oncology Monica Manepalli, Sr.CSV/CSA Consultant Compliance Group
9:30 - 10:10 AM
Select Between Knowledge Exchange Sessions
9:30 - 10:10 AM
How to Modernize Risk Assessments with Critical Thinking
Sachin Bhandari, Head of CSV and Qualification Standards Boehringer Ingelheim International GmbH
9:30 - 10:10 AM
AI and GxP - Review of GxP Use Cases and Regulatory Developments
Loganathan Kumarasamy, Head – Scientific Informatics & Compliance Services Zifo Technologies Inc.
10:20 - 11:00 AM
Select Between Knowledge Exchange Sessions
10:20 - 11:00 AM
Auditing Vendors for Compliance and Risk
Leslie Lighton-Humphreys, Senior Manager Compliance and Process Management Cencora
10:20 - 11:00 AM
Beyond Patterns: How AI Can Help Find the Root Causes of Validation Issues
William Gargano, Group SVP, IT & Life Sciences RCM Data & Solutions Rene Marcotte, SVP, Data Analytics & Life Sciences RCM Data & Solutions
11:10 - 11:50 AM
Select Between Knowledge Exchange Sessions
11:10 - 11:50 AM
Agile Computer Software Assurance (CSA)
Jeff Ramos, Engineer Industry Solutions ValGenesis
11:10 - 11:50 AM
Digital Threads and Data Integrity Governance
Leslie Lighton-Humphreys, Senior Manager Compliance and Process Management Cencora
12:00- 12:40PM
Select Between Knowledge Exchange Sessions
12:00- 12:40PM
Scripted and Unscripted Testing - Requirements and Criticality Assessments
Ray Murphy, Software Quality Engineering Fellow Boston Scientific
12:00- 12:40PM
Going Paperless: Digitalization Implementation & Validation - A Case Study
Margaret Hindley PhD, CQA, CQE, Director CSA/IT Taiho Oncology Khaled Moussally, Executive Vice President, Corporate Development & Operations Compliance Group
12:40- 1:40PM
Networking Luncheon
12:40- 1:40PM
Ask The FDA: Bring Your Compliance Questions
1:40-2:20PM
Select Between Knowledge Exchange Sessions
1:40-2:20PM
So, You’ve Transitioned to CSA, Now What? (Challenges & Opportunities)
Harsha Chulki, Head of Global IT Quality & Compliance ICU Medical
1:40-2:20PM
Panel Discussion: Implementing Test Automation and Digital Validation in HLS
Christian Gaden, IT Manager, Program Management and Quality Assurance New England Biolabs Radha Ramesh, Director, IT Compliance Ultragenyx Michael Sieve MBA, Health and Life Sciences Manager TTC Global
2:30-3:10PM
Select Between Knowledge Exchange Sessions
2:30-3:10PM
Qualification of Saas/Cloud Platforms & External Facing Applications
Pranita Barve, Validation Lead ZS Princeton, NJ Laurent Saugrin, Associate Director Computer Software Assurance CAI Vinodh Rodrigues, VP, Customer Success Quartic.ai
2:30-3:10PM
Computer Software Assurance through Digitalization
Leslie Lighton-Humphreys, Senior Manager Compliance and Process Management Cencora
3:10-3:30PM
Exhibitor Showroom and Refreshment Break
3:30-4:10PM
Select Between Knowledge Exchange Sessions
3:30-4:10PM
Implications and Opportunities of CSA on Part 11
Ray Murphy, Software Quality Engineering Fellow Boston Scientific
3:30-4:10PM
Digitalization Hot Topics - Automated Testing, Mobile Apps, and Cybersecurity
Harsha Chulki, Head of Global IT Quality & Compliance ICU Medical
4:20-5:00PM
Select Between Knowledge Exchange Sessions
4:20-5:00PM
Conduct a Gap Analysis of Your Current Program and Transition to CSA
Carlos L Pereira, Regional Manager of US Midwest & Canada VTI Life Sciences
4:20-5:00PM
Human Centered Design – Soft Skills Needed for Digitalization
Rohit Tyagi, Head of Quality and Compliance SagaxTeam
Lean Validation: Elevate Your Processes with Computer Software Assurance and Digitalization
In today’s rapidly evolving landscape, where the FDA’s new guidance and cutting-edge digital platforms, including generative AI, are shaping the future, it’s paramount to reassess your organization’s practices. Now is the time to modernize your processes for optimal efficiency and compliance.
Unlock a World of Possibilities with Over 15+ Tutorials Covering Today’s Top Challenges
Computer Software Assurance Implementation:
- Conduct a Comprehensive Gap Analysis and Transition Seamlessly to CSA
- Dive into Scripted and Unscripted Testing, Assessing Requirements and Criticality
- Navigate Post-Transition Challenges: Training Programs, Change Control, Continuous Monitoring
Digitalization Implementation and Validation:
- Embrace Human-Centered Design: The Soft Skills Essential for Successful Digitalization
- Explore the Journey to a Paperless Environment: Case Studies and Best Practices
- Harness the Power of Digital Threads and Ensure Data Integrity Governance
- Innovative Approaches: Leveraging ChatGPT & Generative AI in Validation
- Delve into Real-World Case Studies: Implementing Machine Learning and Digital Twins
Targeted Audience – Professionals from the following domains are encouraged to attend:
- Validation
- Quality Assurance
- Engineering
- IT
- Data Integrity
- Quality Control
- Manufacturing Management
- Regulatory Affairs
Special Invitation:
This event is also tailored for business development and sales managers offering innovative solutions such as IT department enhancements, paperless validation platforms, and validation consultancy services.
Join us as we navigate the future of validation and digitalization together!