Conference Compendium

Computer and Software Validation EU | IVT

As computer and software validation programs have evolved, industry, FDA and other global agencies have a variety of resources from which to learn and develop a position from which to operate. Although some may not be directly applicable to all areas of validation, they are none-the-less used and expectations are set from them.  

Computer and software validation practices are quickly evolving with the emergence of virtual networks, cloud computing and social media. The urgency of securing data integrity and complying with global regulations has never been greater.  This industry-driven, landmark event aligns global regulations, best practices and case studies featuring the best of CSV.

This conference overviews essential global guideposts, best practices, vendor qualification, and roadmaps used for computer and software validation practice.

A Case Study in Implementing an Effective CSV Program
Chris Reid, Principal Consultant, Integrity Solutions, Ltd.

Applying a Risk-Based Approach to Computerized Systems Validation
Javier Hernandez-Diaz, Auditor IV, Boehringer-Ingelheim

Applying Risk Management in Change Control Processes for Computerized Systems
Joseph Zec, Corporate Software Quality Assurance Manager, Boston Scientific Corporation, Inc.

Auditing Vendors on CSV Processes
Deborah S. Turner, Associate Director, Computer and Automation Validation, Alkermes, Inc.

Automate Your CSV Process Templates, Tools & Tricks
Tyson M. Mew, President, Ofni Systems, Inc.

Bringing Legacy Systems into Compliance
Deborah S. Turner, Associate Director, Computer and Automation Validation, Alkermes, Inc.

Develop a Lifecycle Approach to Computer Validation
Erik Muegge, M.S., PMP, Manager, Quality and Compliance, Abbott Diagnostics General

Develop Extraordinarily Powerful Test Scripts
Joseph Zec, Corporate Software Quality Assurance Manager, Boston Scientific Corporation, Inc.

Developing a Robust CSV Training Program
Erik Muegge, M.S., PMP, Manager, Quality and Compliance, Abbott Diagnostics General

If IT is from Mars and QA is from Venus, how do I make a CSV Project Deadline?
Deborah S. Turner, Associate Director, Computer and Automation Validation, Alkermes, Inc.

Estimation The What and the How or: How I Learned to Stop Worrying and Love Quality
Joseph Zec, Corporate Software Quality Assurance Manager, Boston Scientific Corporation, Inc.

Implement FDA’s New Process Validation Guidance and Other Global Initiatives into Computer and Software Validation Practice
Erik Muegge, M.S., PMP, Manager, Quality and Compliance, Abbott Diagnostics General

Implementation and Validation of a Global Chromatography Data Management System (CDMS)
Javier Hernandez-Diaz, Auditor IV, Boehringer-Ingelheim

Leveraging Vendors for a Risk Risk-Based Approach to Validate COTS Software Pros, Cons, and Caveats
Dana Yurach, Senior Product Manager, Compliance, Waters Corporation

Manage Software Development, Testing, and Validation
Sharon Strause, Senior Consultant, EduQuest, Inc.

Network Infrastructure Qualification: Where Do You Start and End?
Sharon Strause, Senior Consultant, EduQuest, Inc.

Optimize CSV by Selecting Qualified Vendors
Claus le Fevre, M.Sc., Consulting Director, NNIT A/S

Prepare for FDA CSV Inspections
Tyson M. Mew, President, Ofni Systems, Inc.

The Importance of Who does What and Why: A Handrail for the Validation Function against the Every Day Chaos
Willi Ramseier, Senior Systems Validation Analyst, Hoffmann-La Roche Ltd

Use Macros, Spreadsheets and Databases in Regulated Environments
Tyson M. Mew, President, Ofni Systems, Inc.

Validation of Computerized System
Chris Reid, Principal Consultant, Integrity Solutions, Ltd.

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