Early Bird Pricing Ends Friday, January 26, 2024!
AGENDA
7:00
Exhibitor Showroom and Virtual Platform Open House
7:45
Chairman's Opening Remarks
8:00 - 8:55
Compliance Intelligence Panel Discussion: Navigate the Maze of Regulations Affecting Validation - FDA's CSA, Annex 1, ICH Q9r1, Quality Metrics and More
"Panelists: Cindy Duhigg, Global Process Validation Steward, Alcon Dawn Marshall (Tavalsky), Global External Manufacturing - Quality, Sanofi"
9:00 - 9:25
A Sustainable Model for Production System Excellence
WoonLit Ong, Senior Director, APAC & AfME Operational Excellence, Pfizer Global Supply (PGS)
9:30 - 10:00
Continuous Process Validation and Holistic Control Strategy - Thinking Beyond CPP-Based Critical Aspects
Chip Bennett, Associate Director, Global CQV, CAI
10:00 -10:30
Exhibitor Showroom and Refreshment Break
10:30 - 11:10
A CSA Maturity Model – Challenges, Breakthroughs, and Measures of Success
Ken Shitamoto, Executive Director, Gilead Sciences
11:20 - 12:00
Annex 1 - Designing the Process to Prevent Contamination
Dawn Marshall (Tavalsky), Global External Manufacturing - Quality, Sanofi
12:00 - 1:00
Networking Luncheon - Round Table Luncheon
1:00 - 1:40
Select Between Knowledge Exchange Sessions
Using A.I. in Validation
Ken Shitamoto, Executive Director, Gilead Sciences
PROCESS VALIDATION
Modern Risk-based Process Validation - Program Implementation & Maintenance Case Study
Cindy Duhigg, Global Process Validation Steward, Alcon
1:50 - 2:30
Select Between Knowledge Exchange Sessions
Computer / Software
Build a Modern Risk-Based CSV Program - An End-to-End Lifecycle Model
Kalpesh Patel, Associate Director QA, BeiGene
Change Control
Mitigate Risk when Making Changes to Validated Systems
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
2:30 - 3:30
Speed Training and Networking - Discover Innovative Processes and Technology
3:30 - 4:10
Select Between Knowledge Exchange Sessions
CSV/CSA
Risk Management for Scripted and Unscripted Testing
Ian Lucas, Director and Training Manager, SeerPharma Pty Ltd
Knowledge Management
Knowledge Management in Validation - Using Emerging Technology for Continuous Improvement
Praveen Kalluri, Sr. Director of Quality Assurance - Global Validation, PTC Theraputics
4:20 - 5:00
Select Between Knowledge Exchange Sessions
CSV Hot Topics
Hot Topics - Digitalization, Spreadsheet, and Cloud Qualifications
NOVATEK
PROCESS VALIDATION
Qualifying Your Manufacturing Line - Develop a Process Validation Strategy
Kalpesh Patel, Associate Director QA, BeiGene
5:00 Close of Day One and Networking Cocktail Reception
Close of Day One and Networking Cocktail Reception
7:30
Exhibitor Showroom and Virtual Platform Open House
8:30 - 9:10
Select between knowledge exchange sessions
Cleaning Validation
Cleaning Validation Training Program - Implementation and Measuring Success
Dawn Marshall (Tavalsky), Global External Manufacturing - Quality, Sanofi
Equipment Qualification
Mastering IQ/OQ/PQ and Impact Assessments
Kalpesh Patel, Chief Operating Officer, Hyde Engineering + Consulting
9:20 - 10:00
Select Between Knowledge Exchange Sessions
Cleaning Validation
Navigating Challenges in Cleaning Validation
Chai Richard, Senior Technical Service Manager, STERIS Corporation
Utility Qualification
Qualifying Critical Utility Systems - HVAC, Water, and Process Gasses
David W. Vincent, Chief Scientifc Officer, VTI Life Sciences
10:00
Exhibitor Showroom and Refreshment Break
10:30 - 11:10
Select Between Knowledge Exchange Sessions
Cleaning Validation
Cleaning Validation Program Design - A Risk-based Lifecycle Approach (including Health Limits)
Kalpesh Patel, Chief Operating Officer, Hyde Engineering + Consulting
Utility Qualification
Annex 1 and the Benefits of Digitalization of Risk-Based Cleaning Validation for a Contamination Control Strategy (CCS)
Parsa Famili, President & CEO, Novatek International
11:20 - 12:00
Select Between Knowledge Exchange Sessions
Smoke Studies
Using Smoke Studies as a Risk Tool
Dawn Marshall, Global Quality - Site Support, Sanofi
Process Mapping
Data Integrity Risk Management through Process Mapping
Rahul Songire, Vice President - Central Quality, Zydus
12:00
Roundtable Topics Luncheon
1:15 - 1:55
Select Between Knowledge Exchange Sessions
Validation Statistics
Using Statistics as a Risk Tool throughout the Process Validation Lifecycle
Cindy Duhigg, Global Process Validation Steward, Alcon
Process Validation
How to Use Risk Throughout the Process Validation Lifecycle
David W. Vincent, Chief Scientifc Officer, VTI Life Sciences
2:05 - 2:45
Select Between Knowledge Exchange Sessions
Process Control
Statistical Process Control and the Use of Control Charts
Rajnish Narula, Director Buisness Excellance, Pfizer
Validation Documentation
Best in Class Master Plans, SOPs, Checklists and Templates in Validation
Praveen Kalluri, Sr. Director of Quality Assurance - Global Validation, PTC Theraputics
2:45 - 3:00
Exhibitor Showroom and Afternoon Stretch
CSV/CSA
How to Use A.I., ChatGPT, & Machine Learning in Validation
Ian Lucas, Director and Training Manager, SeerPharma Pty Ltd
Inspection Readiness
Ensure You Are GMP and Validation Inspection Ready
Kalpesh Patel, Associate Director QA, BeiGene
3:50 - 4:30
Select Between Knowledge Exchange Sessions
Single Use Systems
Validation of Single Use Systems (SUSs)
G. Somasundaram, Senior Consultant , Asia Pacific, Process Solutions, Merck Life Science
Visual Inspection
Learn How to Validate Visual Inspection Systems
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
4:30 ET
Close of Day Conference
Validation University Singapore
Join us for a 2-day conference and training program that will provide the latest knowledge and best practices in validation for the life sciences industry! The conference will cover a wide range of topics, including process validation, cleaning validation, computer system validation, equipment validation, facility qualification, data integrity, and quality metrics. Speakers will be industry experts who will share their insights and experiences on how to implement effective validation programs. The conference will also offer networking opportunities and hands-on training sessions.
Key benefits of attending Validation University Singapore include:
- Learn from industry experts and gain insights into the latest validation trends including A.I. and CSA/CSV
- Get hands-on training in validation techniques, best practices, and case studies
- Network with other professionals in the life sciences industry
- Stay up-to-date on the latest regulatory requirements
If you are involved in validation in the life sciences industry, then Validation University Singapore is a valuable event that you should consider attending.
Personnel In The Following Environments Should Attend:
• Validation
• Quality Assurance
• Engineering
• IT
• Data Integrity
• Quality Control
• Manufacturing Management
• Laboratory Management
• Regulatory Affairs
