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Validation University
March 5-6, 2024 I Singapore
Hotel: Voco Orchard Hotel
Address: 581 Orchard Rd Singapore, 238883 Singapore

PLATINUM

GOLD
EXCHANGE KNOWLEDGE WITH OUR ELITE FACULTY

Chip Bennett Rajnish Narula

Associate Director Director Business
Global CQV Excellence
CAI Pfizer

Richard Chai WoonLit Ong

Senior Technical Service Senior Director
Manager Operational Excellence
STERIS Corporation Network Lead
Pfizer Global Supply (PGS)

Cindy Duhigg
Global Process Ken Shitamoto
Validation Steward Executive Director
Alcon Gilead Sciences

Parsa Famili G. Somasundaram

President & CEO Senior Consultant
Novatek International Asia Pacific, Process Solutions
Merck Life Science

Kalpesh Patel
Associate Director QA Rahul Songire
BeiGene Vice President
- Central Quality
Zydus
Praveen Kalluri
Sr. Director of Quality
Assurance - Global Validation, Raul Soto
PTC Therapeutics Senior Principal Engineer
Johnson & Johnson Vision Care

Shanshan Liu
Technical Director Ankur Verma
No Deviation Director CQV Asia Pacific
Hyde Engineering + Consulting

Ian Lucas
Director and Training David W. Vincent
Manager Chief Scientific Officer
SeerPharma Pty Ltd VTI Life Sciences

Dawn Marshall (Tavalsky) Pierre Winnepenninckx

Global External Manufacturing CEO
- Quality No Deviation Pte Ltd
Sanofi
 Day One March 5, 2024

7:45 AM Registration & Exhibitor Showroom Opens | Lite Breakfast

8:45 - 9:00 AM Chairman's Opening Remarks

9:00 - 10:20 AM Panel: Compliance Intelligence Panel Discussion: Navigate the Maze of
Regulations Affecting Validation - FDA's CSA, Annex 1, ICH Q9r1, Quality
Metrics and More
Moderator:
David W. Vincent, Chief Scientifc Officer, VTI Life Sciences

Panelists:
Cindy Duhigg, Global Process Validation Steward, Alcon
Parsa Famili, President & CEO, Novatek International
Dawn Marshall (Tavalsky), Global External Manufacturing - Quality, Sanofi
Pierre Winnepenninckx, CEO, No Deviation Pte Ltd

10:30 - 11:10 AM Select Between Knowledge Exchange Sessions

A Sustainable Model for Production System Excellence

Production Excellence WoonLit Ong, Senior Director, Operational Excellence Network Lead,
Pfizer Global Supply (PGS)

Continuous Process Validation and Holistic Control Strategy - Thinking

Continuous Validation Beyond CPP-Based Critical Aspects
Chip Bennett, Associate Director, Global CQV, CAI

Exhibitor Showroom and Refreshment Break

11:20 - 12:00 AM Select Between Knowledge Exchange Sessions

Pragmatic CSA
Software Assurance
Ken Shitamoto, Executive Director, Gilead Sciences

Annex 1 - Designing the Process to Prevent Contamination

Annex 1
Dawn Marshall (Tavalsky), Global External Manufacturing - Quality, Sanofi

12:00 - 1:00 PM Networking Luncheon - Round Table Luncheon

1:10 - 1:50 PM Select Between Knowledge Exchange Sessions

Using A.I. in Validation

Other
Ken Shitamoto, Executive Director, Gilead Sciences

Modern Risk-based Process Validation - Program Implementation &

Process Validation Maintenance Case Study
Cindy Duhigg, Global Process Validation Steward, Alcon

2:00 - 2:40 AM Select Between Knowledge Exchange Sessions

Build a Modern Risk-Based CSV Program - An End-to-End Lifecycle Model

Computer / Software
Kalpesh Patel, Associate Director QA, BeiGene

2
 Day One March 5, 2024

Mitigate Risk when Making Changes to Validated Systems

Change Control
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care

Speed Training and Networking - Discover Innovative Processes and

2:50 - 3:50 PM Technology

4:00 - 4:40 PM Select Between Knowledge Exchange Sessions

Risk Management for Scripted and Unscripted Testing

CSV/CSA
Ian Lucas, Director and Training Manager, SeerPharma Pty Ltd

Qualifying Your Manufacturing Line - Develop a Process Validation

Process Validation Strategy
ShanShan Liu, Technical Director, No Deviation

4:50 - 5:30 PM Select Between Knowledge Exchange Sessions

Qualifying Critical Utility Systems - HVAC, Water, and Process Gasses

Utility Qualification
David W. Vincent, Chief Scientifc Officer, VTI Life Sciences

Knowledge Management in Validation - Using Emerging Technology for

Knowledge Management
Continuous Improvement
Praveen Kalluri, Sr. Director of Quality Assurance - Global Validation,
PTC Theraputics

5:30 PM Close of Day One and Networking Cocktail Reception

3
 Day Two March 6, 2024

7:30 AM Exhibitor Showroom Opens and Lite Breakfast

8:30 - 9:10 AM Select Between Knowledge Exchange Sessions

Cleaning Validation Training Program - Implementation and Measuring

Cleaning Validation Success
Dawn Marshall (Tavalsky), Global External Manufacturing - Quality, Sanofi

Mastering IQ/OQ/PQ and Impact Assessments

Equipment Qualification
Ankur Verma, Director CQV Asia Pacific, Hyde Engineering + Consulting

9:20 - 10:00 AM Select Between Knowledge Exchange Sessions

Navigating Challenges in Cleaning Validation

Cleaning Validation
Richard Chai, Senior Technical Service Manager, STERIS Corporation

Hot Topics - Digitalization, Spreadsheet, and Cloud Qualifications

CSV Hot Topics Ian Lucas, Director and Training Manager, SeerPharma Pty Ltd
Ken Shitamoto, Executive Director, Gilead Sciences

10:00 - 10:25 AM Exhibitor Showroom and Refreshment Break

10:30 - 11:10 AM Select Between Knowledge Exchange Sessions

Using Smoke Studies as a Risk Tool

Smoke Studies
Dawn Marshall, Global Quality - Site Support, Sanofi

Annex 1 and the Benefits of Digitalization of Risk-Based Cleaning

Annex 1 Validation for a Contamination Control Strategy (CCS)
Parsa Famili, President & CEO, Novatek International

11:20 - 12:00 PM Select Between Knowledge Exchange Sessions

Cleaning Validation Program Design - A Risk-based Lifecycle Approach

Cleaning Validation (including Health Limits)
TBD

Data Integrity Risk Management through Process Mapping

Process Mapping
Rahul Songire, Vice President - Central Quality, Zydus

12:10 - 1:10 PM Roundtable Topics Luncheon

1:20 - 2:00 PM Select Between Knowledge Exchange Sessions

Using Statistics as a Risk Tool throughout the Process Validation Lifecycle

Validation Statistics
Cindy Duhigg, Global Process Validation Steward, Alcon

4
 Day Two March 6, 2024

How to Use Risk Throughout the Process Validation Lifecycle

Process Validation
David W. Vincent, Chief Scientific Officer, VTI Life Sciences

2:10 - 2:50 PM Select Between Knowledge Exchange Sessions

Statistical Process Control and the Use of Control Charts

Process Control
Rajnish Narula, Director Business Excellence, Pfizer Global Supply (PGS)

Best in Class Master Plans, SOPs, Checklists and Templates in Validation

Validation
Documentation
Praveen Kalluri, Sr. Director of Quality Assurance - Global Validation,
PTC Theraputics

3:00 - 3:20 PM Exhibitor Showroom and Afternoon Stretch

3:30 - 4:10 PM Select Between Knowledge Exchange Sessions

How to Use A.I., ChatGPT, & Machine Learning in Validation

CSV/CSA
Ian Lucas, Director and Training Manager, SeerPharma Pty Ltd

Ensure You Are GMP and Validation Inspection Ready

Inspection Readiness
Kalpesh Patel, Associate Director QA, BeiGene

4:20 - 5:00 PM Select Between Knowledge Exchange Sessions

Validation of Single Use Systems (SUSs)

Single Use Systems G. Somasundaram, Senior Consultant , Asia Pacific, Process Solutions,
Merck Life Science

Learn How to Validate Visual Inspection Systems

Visual Inspection
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care

5:00 PM Close of Conference

5
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