COMPUTER SYSTEMS VALIDATION & SOFTWARE ASSURANCE UNIVERSITY

EARLY BIRD PRICING ENDS FRIDAY, NOVEMBER 10!

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





CAI









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.

Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Single Admission - Manufacturers
$ 1,595.00 $ 1,295.00 $1,295.00
Unlimited
TEAM DISCOUNT
Save $300 per ticket when you register 5 or more team members!
$ 1,295.00 $ 995.00 $995.00
Unlimited
Single Admission - Solution Providers
$ 1,995.00 $ 1,695.00 $1,695.00
Unlimited
Temple Track - Single Admission
$ 1,595.00 $ 1,295.00 $1,295.00
Unlimited
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