EARLY BIRD PRICING ENDS FRIDAY, NOVEMBER 10!
AGENDA
9:00 - 10:00
Registration, Exhibitor Showroom, and Refreshments
10:00 - 12:00
Implement a CSV & SA Training Program and Measure for Success
Dori Gonzalez-Acevedo, CEO, ProcellaRX
10:00 - 12:00
Develop a Problem Solving Leadership Program
Jeffrey G. Soper, Ph.D., Executive Director, ISBPI INC
12:00 - 1:00 PT
Exhibitor Showroom and Grab & Go Lunch
1:00 PT
Chairman's Opening Remarks
1:15 - 2:15 PT
(Panel) Compliance Intelligence - Stay Up to Speed with the Regulatory and Validation Landscape - CSA, AI/ML, Superintelligence Governance
Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA; Daniel Walter, Policy Analyst, CDRH, U.S. FDA; Rohit Tyagi, CEO, Head of Quality & Compliance, Sagax Team; Radha Ramesh, Director, IT Compliance and V&V, Ultragenyx
2:15 - 3:00 PT
Use Cases in Successful CSA Transition
Linda Lagrou, Senior Manager IT Quality, Abbott Laboratories; Gaurav Walia, Senior Global Director, Principle SME in DI/CSV/CSA, PQE Group
3:00 - 3:30 PT
Exhibitor Showroom and Refreshment Break
3:30 - 4:30 PT
(Panel) Digitalization, AI/ML, Superintelligence Platforms, and Compliance
David DeLuca Director, Engineering & Validation, Compliance Group; Ravi Nabar, Senior Director Quality, Thermo Fisher Scientific; Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA
4:30 - 5:15 PT
Validation of AI/ML and other Superintelligence Platforms
Steve Thompson, Senior Director Product Marketing, ValGenesis, Inc,
5:00 PT
Welcome Networking Reception
7:15 PT
Exhibitor Showroom Opens and Lite Breakfast
8:00 - 9:20 PT
Digitalization Validation Demo Day
9:20 - 10:00 PT
Software Fundamentals - Writing Test Scripts to Support CSA
Vignesh Srinivas, Manager – Compliance Services (CSA/CSV), Zifo Technologies Inc.
9:20 - 10:00 PT
Qualifying SaaS, IaaS - Create a Quality Agreement with Cloud Providers
Sachin Bhandari, Head of CSV and Qualification Standards, Boehringer Ingelheim
9:20 - 10:00 PT
Implement Data Integrity Controls that Minimize Error
Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting
10:00 -10:30 PT
Exhibitor Showroom and Refreshment Break
10:30 - 11:10 PT
The Intersection of Risk Analysis, Critical Thinking and Modern Testing
Madhavi Ganesan, Life Sciences Solutions Director, and Mihir Solanki, Manager, Healthcare and Life Sciences Advisory, KPMG
10:30 - 11:10 PT
Cyber Compliance with the Software Lifecycle
Elizabeth Warnock, Director, IT Quality and Compliance, Abbott Laboratories
10:30 - 11:10 PT
The Interrelationship between CSV and the Secure Supply Chain (SSC) and the Drug Supply Chain Security Act (DSCSA)
Leslie Lighton-Humphreys, IT CSV & SQA Manager, Cencora
11:20 - 12:00 PT
Validation and Change Control for Software Upgrades
Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
11:20 - 12:00 PT
Data Integrity Process Mapping - Identify and Mitigate Gaps
Kim Huynh-ba, Managing Director, Pharmalytik
11:20 - 12:00 PT
ALM Tools Add Value to Software Validation
Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care
12:00 PT
Exhibitor Showroom and Networking Luncheon
1:30 - 2:10 PT
Qualifying Network and IT Infrastructures
Radha Ramesh, Director, IT Compliance and V&V, Ultragenyx
1:30 - 2:10 PT
Cultivate a CSV Quality Culture
Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
1:30 - 2:10 PT
A Roadmap to Successful CSA Implementation - Case Study
Brian DiVasta, Director, CSV, ElevateBio
2:20 - 3:00 PT
Key Components to Consider when Transitioning to CSA
Ken Shitamoto, Executive Director, Gilead Sciences
2:20 - 3:00 PT
Conduct Risk-based Impact Assessments of Computer Systems
Rohit Tyagi, CEO, Head of Quality & Compliance, Sagax Team
2:20 - 3:00 PT
Automate Decision Making to Accelerate Process – Use Case from Company Spin off
Geetanjali Abbi, Director Validation, Alkermes; Brandi Stockton, Co-Founder and Principal Consultant, The Triality Group
3:00 - 3:30 PT
Exhibitor Showroom and Refreshment Break
3:30 - 4:10 PT
Elevate Your Tech Game: The CSV Op Model Deciphered
Joanne Goldberg, Senior Principal Technical Analyst, Medtronic; Paul Anderson, Senior Organizational Change Management Lead, DRChange, LLC
3:30 - 4:10 PT
Maximize the Benefits of CSA for Test Driven Agile Validation
Jacob Hodovsky, Computer System Validation Engineer, CAI
3:30 - 4:10 PT
CSV ROI for Business Sake - Balancing Quality vs. Cost Management
Ed Hein, Senior Manager, Digital Product Excellence, LifeScan Global Corp
4:20 - 5:00 PT
Learn How to Validate Big Data - Ensure Quality in Complex Platforms
Ivan Soto, Senior Director Quality Assurance Validation, Sarepta Therapeutics
4:20 - 5:00 PT
Conduct a GAMP® 5 Assessment - Use a Customized Checklist
Keith Ulrich, Global Director, Computer System Validation, Ashfield Engage an Inizio Company
4:20 - 5:00 PT
CSA and the Implementation of New Technologies - IoT, Wearables, Big Data Using Risk and Modern Testing Techniques
Madhavi Ganesan, Life Sciences Solutions Director, and Mihir Solanki, Manager, Healthcare and Life Sciences Advisory, KPMG
5:00 - 5:40 PT
Awareness of Risks and Mitigation strategies Throughout CS Lifecycle
Geetanjali Abbi, Director Validation, Alkermes
5:00 - 5:40 PT
Computerized System Validation (CSV) Process Innovation (PI) - Modernization Your Approach
Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care
5:40 PT
Close of Day Two
7:15 PT
Exhibitor Showroom Opens, DEI Roundtable, and Lite Breakfast
7:55 - 8:35 PT
Risk-based Spreadsheet Validation
Arif Azad, Engineering Validation Manager, Pfizer
7:55 - 8:35 PT
Configuration and Change Management of Computer Systems
Amanda Forsythe, Quality Technology Manager, and Carolina Zapata, Process Development Manager, Agilent Technologies
7:55 - 8:35 PT
Conduct a 21 CFR Part 11 Gap Analysis
Jacob Hodovsky, Computer System Validation Engineer, CAI
8:45 - 10:15 PT
Establish Effective Data Governance Maturity Model
Leslie Lighton-Humphreys, IT CSV & SQA Manager, Cencora
8:45 - 10:15 PT
Agile Development with Software Assurance
Suarabh Joshi Shripad, Director for Solutions Engineering, ValGenesis, Inc.
8:45 - 10:15 PT
A Model for Conducting Digitalization Validation
Sachin Bhandari, Head of CSV and Qualification Standards, Boehringer Ingelheim
10:15 - 10:45 PT
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 PT
Taking the CSV Leap: Adopt, Adapt, Achieve!
Joanne Goldberg, Senior Principal Technical Analyst, Medtronic; Paul Anderson, Senior Organizational Change Management Lead, DRChange, LLC
10:45 - 11:25 PT
Use Cases in Conducting Risk Assessments
Brian DiVasta, Director, CSV, ElevateBio
10:45 - 11:25 PT
How to Use Risk in Decommissioning of Computer Systems and Software Applications
Ivan Soto, Senior Director Quality Assurance Validation, Sarepta Therapeutics
11:35 - 12:15 PT
Scripted vs. Unscripted Testing – Requirements Criticality Assessments
Keith Ulrich, Global Director, Computer System Validation, Ashfield Engage an Inizio Company
11:35 - 12:15 PT
Your Guide to CSV Modernization - An End to End Approach
Nina Ricciardelli, Director of Vault Validation Management, and Robin Smallwood, Manager of Vault Validation Management, Veeva Systems
11:35 - 12:15 PT
Inspection Readiness - Ensuring Systems are Fit for Purpose
Kalpesh Patel, MBA, PMP, CSM, Associate Director, QA, BeiGene
12:15 PT
Exhibitor Showroom and Networking Luncheon
1:00 - 1:40 PT
Effective Collaboration - Streamline Validation Across Validation, Quality, and IT
Ed Hein, Senior Manager, Digital Product Excellence, LifeScan Global Corp
1:00 - 1:40 PT
Discover Best in Class SOPs, Templates, Checklists and Master Plans
Esra Guven, Associate Director, GIS - Computer Systems Validation, Apotex, Inc.
1:00 - 1:40 PT
Validation of Manufacturing Execution Systems (MES)
Carlos Pereira, Regional Manager, VTI Life Sciences
1:50 - 2:30 PT
Developing a Quality Process for AI/ML Based GxP System
Loganathan Kumarasamy, Head – Scientific Informatics & Compliance Services, Zifo Technologies Inc.
1:50 - 2:30 PT
Impact Assessments - Know Which Test Approach to Use During Validation
Amanda Forsythe, Quality Technology Manager, and Carolina Zapata, Process Development Manager, Agilent Technologies
2:30 PT
Refreshment Break
2:45 - 3:25 PT
Amanda Forsythe, Quality Technology Manager, and Carolina Zapata, Process Development Manager, Agilent Technologies
Kim Huynh-ba, Managing Director, Pharmalytik
2:45 - 3:25 PT
Modernize Your 21 CFR Part 11 Program - CSA, Two Factor Authentication, AI/ML
To Be Announced
3:35 - 4:15 PT
How to Use Factory Talk in Historian for Production Data to Meet FDA Compliance
Carlos Pereira, Regional Manager, VTI Life Sciences
3:35 - 4:15 PT
Use Case for the Validation of Using AI / ML in SaMD
To Be Announced
4:15 PT
Close of Conference
Computer Systems Validation & Software Assurance University
December 5 – 7, 2023 | San Diego, California
CSV & SA University is industry’s largest and most comprehensive program focused on CSV that attracts 200 – 300 participants from the life science industry working in engineering, validation, quality, software development, IT, and regulatory compliance. The multi-track conference offers 40+ tutorials exchanging best practices and sharing challenges including digitization, technology advances, Data Integrity, critical thinking, risk analysis, evolving and traditional CSV trends and dives into emerging challenges such as superintelligence governance, AI/ML, ChatGPT and more. This year, we expect a large turnout because of a myriad of regulatory guidance and trends in AI/ML, CSA, Annex 11 and more. This must attend event includes:
Create Your Own Experience by Choosing from Over 40+ Tutorials, Including:
FDA and Industry Panel Discussions
- Stay Up to Speed with the Evolving Regulatory Landscape for AI, ML and Superintelligence Technology
- The Impact of CSA on Part 11, GAMP® 5, Risk Analysis, Critical Thinking and Test Scripts
Use Cases in Emerging Technology and Top Compliance Trends
- CSA Transition Success
- Artificial Intelligence / Machine Learning Qualification
- Super Intelligence Usage and Governance
- Cloud Platform Qualification
- Data Integrity Maturity Model Implementation
- Risk Analysis and Critical Thinking
Technology Advancement Impact on Traditional CSV Practice
- Spreadsheet Qualification
- Unscripted vs. Scripted Testing
- Risk-based Impact Assessments
- Decommissioning of Systems
- Change Control and Configuration Management
- Program and Process Innovation
- SOPs, Checklists, and Master plans
- Cybersecurity Modernization
PLUS! Attend an Inclusive Digitalization Validation Demo Workshop
- Save Time and Money, Ensure Compliance, Minimize Error/Risk, and Increase ROI
Personnel in the Following Environments Should Attend:
- Validation
- Quality Assurance
- Engineering
- IT
- Data Integrity
- Quality Control
- Manufacturing Management
- Laboratory Management
- Regulatory Affairs
This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, paperless validation platforms, and validation consultant services.
