Validation University 2025
Driving Excellence in Modern Validation & Qualification Processes
Validation University
Welcome to Validation University, the premier event for QA, Validation, Engineering, IT, and RA professionals working in the pharmaceutical, biopharmaceutical, and medical device industries. This comprehensive program is designed to equip you with the latest tools, techniques, and insights to navigate today’s regulatory landscape and enhance your validation processes. With a focus on cutting-edge technologies, emerging trends, and practical applications, Validation University is your gateway to achieving compliance and operational excellence.
Highlighted Sessions
Explore a diverse range of sessions designed to deepen your expertise and provide actionable insights across key validation areas.
- Modernizing Process Validation: Strategies for Stage 1-3 Compliance and Efficiency
- CSV 4.0: Validating AI, SaaS, and Cloud-Based Systems
- Continuous Validation: Staying Compliant in Rapidly Evolving Environments
- Next-Gen Cleaning Validation: Integrating Risk-Based Approaches and Visual Inspection
- Risk-Based Approach to Computer Systems Validation: Simplifying Compliance
- Ensuring Compliance: Utility Qualification for Water, HVAC, and Compressed Air Systems
- Advanced Statistical Approaches: Process Capability, Sampling Plans, and Control Limits
- Facility Qualification: Ensuring Regulatory Compliance Through Effective Design and Execution
- Quality Risk Management (QRM): Integrating ICH Q9 into Validation Processes
- Automated Validation Systems: Reducing Human Error and Increasing Efficiency
Industry & Emerging Trends
Stay ahead of the curve with sessions that delve into the most transformative trends shaping the industry today:
- Adopting Industry/Pharma 4.0: Integrating AI and Machine Learning into Validation (Panel)
- Digital Validation Tools: Harnessing Data Analytics and Predictive Modeling for the Future (Panel)
- Driving Collaboration: Standardization and Best Practices Through Information Sharing
- Computer Software Assurance (CSA): Shifting from Compliance to Critical Thinking
- Validation in Continuous Manufacturing: Ensuring Compliance in Real-Time Processes
- Lean Validation: Driving Efficiency and Reducing Costs in Complex Projects
- Data Integrity Beyond ALCOA: Addressing Current Challenges in Digital Validation
- Validation Master Plans: Blueprinting Success for Compliance and Efficiency
- Single-Use Systems in Validation: Balancing Flexibility and Compliance
- Audit Trails: Ensuring Data Integrity in a Digital Era
PLUS: So Much More!
Take advantage of exclusive opportunities to connect with industry experts, participate in engaging roundtable discussions, and learn the latest insights in validation practices. The program is packed with expert-led sessions, interactive panels, and unique networking opportunities tailored to meet the needs of today’s validation professional.
What Past Attendees Are Saying
The Validation University was a very valuable event. The speakers were all knowledgeable and offered different perspectives, from vendor, to CSV and Quality roles, to FDA. All sessions I attended were informative and interesting. – Associate Director CSV, GMP Systems, Spark Therapeutics
The event was great, had a chance to network and make connections. It was very great to be able to get feedback from FDA speakers and getting a lot of information from great speakers such as Cindy, Ivan, and Doug. Definitely worth it and would go to another one in the future. – Senior Quality Engineer, Diamond Wipes
This was the first time I attended a conference, and it was a very educational experience. – Quality Lead, Diamond Wipes
This was an excellent event; good material was shared and great insight into new initiatives and draft guidance. – Director of Validation, Valid8GMP
KENX provided an ideal balance of emerging technology – which is best presented by the innovators themselves – and deep dives into the science and regulatory foundations of Validation, presented by SMEs from industry. – Global Process Validation Steward, Alcon
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email john.kirchner@kenx.org, Call 856-281-7134 or Register using the Temple Track Ticket above.
Faculty
AGENDA
7:20 - 8:20 AM
Registration - Coffee & Tea
8:20 - 8:30 AM
Chairperson's Opening Remarks
8:30 - 9:00 AM
Keynote
FDA Warning Letters: Top Validation Issues and Industry Trends
Daniel Walter, Policy Analyst, CDRH, U.S. FDA (Invited)
9:00 - 10:00 AM
Panel
Adopting Industry/Pharma 4.0: Integrating AI and Machine Learning into Validation
Moderator: Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Sr. Associate Partner, PQE Group
Panelists:
Aldelberto Cordova, Head of Quality Emerald Cloud Lab
Connie Hetzler, Global Validation Head, Alcon Laboratories (Invited)
Louie Rayal, VP of Governance Risk and Compliance, GSK
Daniel Walter, Policy Analyst CDRH, U.S. FDA (Invited)
10:00 - 10:30 AM
Exhibitor Showroom and Refreshment Break
10:30 - 11:00 AM
Keynote
Navigating Cost and Resource Constraints: Balancing Efficiency with Quality
Connie Hetzler, Global Validation Head, Alcon Laboratories (Invited)
11:00 - 12:00 PM
Panel
Modernizing Process Validation: Strategies for Stage 1-3 Compliance and Efficiency
Presenter: Jorge A. Cordero, Validation Manager, Bausch+Lomb
Panelists:
Joanne Goldberg, Sr. Principal Business Analyst, Medtronic
Giovana Mobiglia, Process Validation Engineer, Pfizer
12:00 - 1:00 PM
Roundtable Luncheon - Topics Include:
VMP
Validation Master Plans: Blueprinting Success for Compliance and Efficiency
Leslie Lighton-Humphreys, Senior Manager Compliance and Process Management, Cencora
Single-Use
Single-Use Systems in Validation: Balancing Flexibility and Compliance
Aldelberto Cordova, Head of Quality Emerald Cloud Lab
Decommisson
Decommissioning with Confidence: Validation Strategies for Equipment Lifecycle Management
Joscelyn Bowersock , Senior Director Quality Assurance and Regulatory, Precision for Medicine
1:00 - 1:40 PM
Select Between Knowledge Exchange Sessions
Digitalization
Digital Validation Tools: Harnessing Data Analytics and Predictive Modeling for the Future
Moderator:
Khaled Moussally, Executive Vice President, Corporate Development & Operations, Compliance Group
Panelists:
Francisco Vicenty (Former FDA), Director of Continuous Improvement, Getinge
Parsa Famili, President & CEO Novatek International
Daniel Walter, Policy Analyst CDRH, U.S. FDA (Invited)
CSV
CSV 4.0: Validating AI, SaaS, and Cloud-Based Systems
Subhabrata Purakayastha, Associate Director and Head of Enterprise GxP IT Systems Quality, Incyte Corporation
Industry Trends
Lean Validation: Driving Efficiency and Reducing Costs in Complex Projects
Joanne Goldberg, Sr. Principal Business Analyst, Medtronic
1:50 - 2:30 PM
Select Between Knowledge Exchange Sessions
Process
Redefining Medical Device Process Validation: Bridging Design, Risk, and Real-World Performance
Francisco Vicenty (Former FDA), Director of Continuous Improvement, Getinge
CSV
Risk-Based Approach to Computer Systems Validation: Simplifying Compliance
Ken Shitamoto, Executive Director, IT, Gilead Sciences
Industry Trends
Automated Validation Systems: Reducing Human Error and Increasing Efficiency
Joachim Gutheil, Manager IT Quality, Abbott BTS, (Business & Technology Services)
4:20 - 5:00 PM
Select Between Knowledge Exchange Sessions
Statistics
Avoid Mistakes with Statistics: Sampling Plans, Process Capability and SPC
Tara Scherder, Principal, SynoloStats
Equipment
Streamlining Equipment Qualification with Lean Validation Principles
Shanna McGovern, Ed.D., President, Guide Star Consulting
Data Integrity
Strengthening Data Integrity: Regulatory Frameworks for Control and Security
Kim Huynh-Ba, M.S., FAAPS, Managing Director Pharmalytik LLC and Adjunct Faculty, RAQA, Temple University
5:00:00 PM
Networking Cocktail Reception
7:30 - 8:30 AM
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 9:10 AM
Select Between Knowledge Exchange Sessions
QRM
Quality Risk Management (QRM): Integrating ICH Q9 into Validation Processes
Chip Bennett,PMP, Senior Director, Project Farma
Equipment
Lifecycle Management of Equipment Qualification: Ensuring Continuous Compliance
Giovana Mobiglia, Process Validation Engineer, Pfizer
Industry Trends
AI and Machine Learning for Validation Trend Analysis and Predictive Maintenance
Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Sr. Associate Partner, PQE Group
9:20- 10:00 AM
Select Between Knowledge Exchange Sessions
Cleaning
Paving the Way for AI: Establishing a Risk-Based Cleaning Validation and Contamination Control Strategy Via Digitalization
Parsa Famili, President & CEO, Novatek International
Equipment
Breaking Down Equipment Qualification: From URS to PQ
Chip Bennett,PMP, Senior Director, Project Farma
Industry Trends
Real Life Industry Trends and Case Studies in AI/Ml: Focus on Validation and Predictive Maintenance
Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Sr. Associate Partner, PQE Group
10:00 - 10:30 AM
Exhibitor Showroom and Refreshment Break
10:30 - 11:10 AM
Select Between Knowledge Exchange Sessions
Cleaning
Driving Sustainability Through Cycle Optimization
Jeff Felker, Deputy Director, Cleaning SME, Sanofi
Dijana Hadziselimovic, Technical Service Manager, STERIS Corporation
Facility
Risk-Based Facility Qualification in Multi-Product and Multi-Use Facilities
David W. Vincent, Chief Scientific Officer (CSO),/B.Sc., MPH, Ph.D., VTI Life Sciences
Industry Trends
IoT and Smart Sensors: Revluationizing Validation and Monitoring
KAYE
11:20 - 12:00 PM
Select Between Knowledge Exchange Sessions
Cleaning
Cleaning Validation in Multi-Product Facilities: Managing Residues and Cross-Contamination
Cindy Duhigg, Senior Principal, Global Manufacturing Science & Technology Engineering, Alcon
Facility
Continuous Improvement in Facility Qualification Through Data-Driven Insights
Dawn Marshall (Tavalsky), Global External Manufacturing – Quality, Sanofi
CSA
CSA Hot Topics: Test Scripts, Critical Thinking, and Risk Assessment
Monica Manepalli, Sr.CSV/CSA Consultant, Compliance Group
12:00 - 1:00 PM
Networking Luncheon - Topics Include:
FDA
Ask the FDA: Your Validation and Compliance Questions Answered
Daniel Walter, Policy Analyst CDRH, U.S. FDA (Invited)
Requalifcaton
Aging Equipment Requalification: Ensuring Compliance Amidst Wear and Tear
Jorge A. Cordero, Validation Manager, Bausch+Lomb
Cleaning
Leveraging Analytical Methods for Robust Cleaning Validation Results
Cindy Duhigg, Senior Principal, Global Manufacturing Science & Technology Engineering, Alcon
1:00 - 1:40 PM
Select Between Knowledge Exchange Sessions
Audit Trails
Audit Trails: Ensuring Data Integrity in a Digital Era
Reshma Kodumuru, Principal CSV, KBI BioPharma
Change Control
Mastering Change Control: Validation Strategies for Planned and Emergency Changes
Arif Azad, Head of TechOps Equipment and Computer System Validation, Pfizer
Industry Trends
From Paper to Digital: Best Practices for Paperless Validation Programs
Jorge A. Cordero, Validation Manager, Bausch+Lomb
1:50 - 2:30 PM
Select Between Knowledge Exchange Sessions
Utility
Ensuring Compliance: Utility Qualification for Water, HVAC, and Compressed Air Systems
David W. Vincent, Chief Scientific Officer (CSO),/B.Sc., MPH, Ph.D., VTI Life Sciences
Data Integrity
Data Integrity Beyond ALCOA: Addressing Current Challenges in Validation
Subhabrata Purakayastha, Associate Director and Head of Enterprise GxP IT Systems Quality, Incyte Corporation
Industry Trends
Remote and Virtual Validation: Ensuring Quality in a Connected World
Leslie Lighton-Humphreys, Senior Manager Compliance and Process Management, Cencora
2:30 - 2:45 PM
Exhibitor Showroom and Refreshment Break
2:45 - 3:25 PM
Select Between Knowledge Exchange Sessions
Utility
Continuous Monitoring in Utility Systems: Ensuring Validation Integrity
Dawn Marshall (Tavalsky), Global External Manufacturing – Quality, Sanofi
Audit
Supplier Auditing and Quality Agreements: Ensuring Compliance and Efficiency
Olivia Calder, Process Engineer, Kneat
Industry Trends
Driving Collaboration: Standardization and Best Practices Through Information Sharing
Joanne Goldberg, Sr. Principal Business Analyst, Medtronic
3:35 - 4:15 PM
Select Between Knowledge Exchange Sessions
Inspections
FDA Inspection Readiness: Preparing Your Validation Documentation for Success
Rishabh Jain, Quality Assurance Manager, Tetrapak
Industry Trends
Validating Modern Enterprise Data Platforms: Balancing Agility with Compliance – Case Study
Shreyans Shah, Director of Quality, Accumulus Synergy
Rohit Tyagi, President, Sagax Team
Cleaning
Next-Gen Cleaning Validation: Integrating Risk-Based Approaches and Visual Inspection
Jeff Felker, Deputy Director, Cleaning SME, Sanofi
4:15 PM
Close of Day Two
Sponsors
