Description
Includes the following presentations:
Modernize CSV & CSA Training Programs – Throw Out Your Read and Understand SOP Playbook
Dori Gonzalez-Acevedo CEO, ProcellaRX
(Panel) CSA – The Foundation for Digital Transformation
David DeLuca Director, Engineering & Validation, and Jason Spiegler, SVP Strategy & Customer Experience, Compliance Group; Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA; Bill Lee, Director of Information Services, DAP Health; Ken Shitamoto, Executive Director, Gilead Sciences
Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study
Linda Lagrou, Senior Manager IT Quality, Abbott Laboratories; Gaurav Walia, Senior Global Director, Principal SME in DI/CSV/CSA, PQE Group
Validation of AI/ML and other Superintelligence Platforms
Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
Industry 4.0 or Validation 4.0 – The Choice is Yours
Ian Lucas, Director / Training Manager, SeerPharma
Software Fundamentals – Writing Test Scripts to Support CSA
Vignesh Srinivas, Manager – Compliance Services (CSA/CSV), Zifo Technologies Inc.
Qualifying SaaS, IaaS – Create a Quality Agreement with Cloud Providers
Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
Implement Data Integrity Controls that Minimize Error
Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting
How Has the Industry Adopted CSA a Year After the FDA Guidance?
Madhavi Ganesan, Life Sciences Solutions Director, KPMG
Cyber Compliance with the Software Lifecycle
Elizabeth Warnock, Director, IT Quality and Compliance, Abbott Laboratories
The Interrelationship between CSV and the Secure Supply Chain (SSC) and the Drug Supply Chain Security Act (DSCSA)
Leslie Lighton-Humphreys, Compliance & Process Management, Cencora
Validation and Change Control for Software Upgrades
Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
ALM Tools Add Value to Software Validation
Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care
Qualifying Network and IT Infrastructures
Radha Ramesh, Director, IT Compliance and V&V, Ultragenyx
Cultivate a CSV Quality Culture
Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
A Roadmap to Successful CSA Implementation – Case Study
Brian DiVasta, Director, CSV, ElevateBio
Key Components to Consider when Transitioning to CSA
Ken Shitamoto, Executive Director, Gilead Sciences
Agile Computer Software Assurance (CSA) in a Low-Code Environment – Building Quality with Efficiency
Daniel Walter, Policy Analyst, CDRH, U.S. FDA; Jonathan Meuzelaar, Director, Quality Systems, Compliance Group
Automate Decision Making to Accelerate Process – Use Case from Company Spin off
Geetanjali Abbi, Director Validation, Alkermes; Brandi Stockton
Elevate Your Tech Game: The CSA Op Model Deciphered
Joanne Goldberg, Senior Principal Technical Analyst, Medtronic; Paul Anderson, Senior Organizational Change Management Lead, DRChange, LLC
Conduct Risk-based Impact Assessments of Computer Systems
Rohit Tyagi, CEO, Head of Quality & Compliance, Sagax Team; Meher Muttanapalli, Senior Manager – Digital & CSV/CSA, Intuitive Surgical
CSV ROI for Business Sake – Balancing Quality vs. Cost Management
Ed Hein, Senior Manager, Digital Product Excellence, LifeScan Global Corp
Robotics and Automation in Life Sciences – Transitioning for Maximum Benefit in Advanced Therapies
Michael Benedict, Ph.D., Robotics and Automation Advisor, Minerva Knowledge Management
Conduct a GAMP® 5 Assessment – Use a Customized Checklist
Keith Ulrich, Global Director, Computer System Validation, Ashfield Engage an Inizio Company
Use Cases: How has CSA been Applied to Advanced Technologies?
Bhaskar Aryasomayajula, Director, Global IT Quality Assurance, Bristol-Myers Squibb; Mihir Solanki, Manager, Healthcare and Life Sciences Advisory, KPMG
Agile Development with Software Assurance
Saurabh Joshi, Director for Solutions Engineering, ValGenesis, Inc
Computerized System Validation (CSV) Process Innovation (PI) – Modernization Your Approach
Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care
Leverage Vendor Testing Under CSA
Amy Wilhite, Senior Process Engineer, Kneat
Risk-based Spreadsheet Validation
Arif Azad, Engineering Validation Manager, Pfizer
Configuration and Change Management of Computer Systems
Amanda Forsythe, Quality Technology Manager, Agilent Technologies Carolina Zapata, Process Development Manager, Agilent Technologies
Establish Effective Data Governance Maturity Model
Leslie Lighton-Humphreys, Compliance & Process Management, Cencora
Awareness of Risks and Mitigation Strategies Throughout CS Lifecycle
Geetanjali Abbi, Director Validation, Alkermes; Brandi Stockton, Co-Founder and Principal Consultant, The Triality Group
Validation for Digital Threads
Jason Spiegler, SVP Strategy & Customer Experience, Compliance Group;
Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA;
Daniel Walter, Policy Analyst, CDRH, U.S. FDA
Jonathan Meuzelaar, Director, Quality Systems, Compliance Group
Colleen Twomey, Director of Staffing Sales, Compliance Group
Taking the CSA Op Model Leap – Plan, Build and Deliver
Joanne Goldberg, Senior Principal Technical Analyst, Medtronic; Paul Anderson, Senior Organizational Change Management Lead, DRChange, LLC
Use Cases in Conducting Risk Assessments
Brian DiVasta, Director, CSV, ElevateBio
How to Use Risk in Decommissioning of Computer Systems and Software Applications
Dori Gonzalez-Acevedo CEO, ProcellaRX
Scripted vs. Unscripted Testing – Requirements Criticality Assessments
Keith Ulrich, Global Director, Computer System Validation, Ashfield Engage an Inizio Company
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; Hong Wa Leong, QA Manager, Computer System Validation, Neurocrine Biosciences, Inc.
Inspection Readiness – Ensuring Systems are Fit for Purpose
Kalpesh Patel, MBA, PMP, CSM, Associate Director, QA, BeiGene
Effective Collaboration – Streamline Validation Across Validation, Quality, and IT
Ed Hein, Senior Manager, Digital Product Excellence, LifeScan Global Corp
Developing a Quality Process for AI/ML Based GxP System
Loganathan Kumarasamy, Head – Scientific Informatics & Compliance Services, Zifo Technologies Inc.
Easy-GxP – Automating Compliance with Regulations and Industry Guidance
Octavian Boca, CEO and Founder, Massachusetts Technology Innovation Corp (MTI)
Impact Assessments – Know Which Test Approach to Use During Validation
Amanda Forsythe, Quality Technology Manager, and Carolina Zapata, Process Development Manager, Agilent Technologies
Discover Best in Class SOPs, Templates, Checklists and Master Plans
Esra Guven, Associate Director, GIS – Computer Systems Validation, Apotex, Inc.
Modernize Your 21 CFR Part 11 Program – CSA, Two Factor Authentication, AI/ML
Roque Redondo, Senior Technical Consultant, Minerva Knowledge Management, LLC
How to Use Factory Talk in Historian for Production Data to Meet FDA Compliance
Carlos Pereira, Regional Manager, VTI Life Sciences
Dump Your Part 11 Checklist – How to Use a Non-checklist Approach
Joanne Goldberg, Senior Principal Technical Analyst, Medtronic
