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Industry's Leader in CSV Excellence

April 25-27, 2018
  • Philadelphia, PA

IVT’s 19th Annual Computer and Software Validation is the flagship industry event for CSV training where quality, validation and IT professionals gather to exchange best practices, stay up to date on current and upcoming regulations and take part in hands-on exercises to put the learning into action.

This year’s highlights include a Case Study Showdown to examine organizational experiences of moving to an agile system, a two-part Documents Management track, and a spotlight session featuring an innovative approach to risk management. With more interactive working sessions, case studies and real-life examples than ever before, IVT’s 19th Annual CSV conference is taking validation excellence to new heights.

FDA SPEAKER JUST ANNOUNCED!

Francisco Vicenty, Program Manager, Case for Quality, Office of Compliance, CDRH, U.S. FDA will be joining us at IVT’s CSV Conference next week to share an update on FDA and Industry’s Collaboration on Non-Product CSV.

Mr. Vicenty will be co-presenting with his industry colleagues, Khaled Moussally, Head of Quality Management Systems at Compliance Group and Jason Spiegler, Senior Director, Industry Portfolio Development at Siemens Product Lifecycle Management Software Inc.

Timely Topics!

  • Examine Organizational Experiences Transitioning to an Agile System
  • Where Do We Stand with Data Integrity in 2018? An Update on the Regulatory Landscape
  • Establish GMP Compliant Cloud Software Validation Procedures

Highly Anticipated Breakouts!

  • Create Strategic Alliances between IT and Quality to Achieve Compliance
  • Death by Documents and How to Avoid It
  • Identify and Integrate Best Practices for Maintaining Data Integrity in Emerging Markets

TWO HANDS-ON WORKSHOPS!

  • Establish a Plan for Transitioning to a Cloud-Based Validation Environment led by Holly Baldwin, Senior Validation Advisor, UL Compliance to Performance
  • Conduct a Self-Assessment of Your Data Integrity Effectiveness through the GAMP Data Integrity Maturity Model led by Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

Enhanced Networking Opportunities!

  • Join the “Extra Inning” Networking Reception on Wednesday
  • Convene with conference peers for dinner on Thursday

 

Previous Attendee Acclaim:

This program has helped me be more multi-faceted in my approach and refresh my knowledge base in the industry.

Senior Validation/Calibration Technical, Prometheus

Excellent forum to share good and bad experiences,
areas in common and best practices.

Senior Validation Manager, Medtronic

Training and data integrity are great topics in CSV
and I’m glad I learned more about it.

Validation Engineer 2, Illumina

Great platform to share knowledge and trends
within the industry.

QA Engineering Manager, Agensys

A great networking experience. Lots of great dialogue.

Quality Specialist III, Thermo Fisher

It was great to hear the similar challenges
from folks in the industry.

CSV Engineer, Bachem

While my company has many good practices in place,
this conference gave me insight into current industry
standards and audit focus. I would recommend this
conference to beginner and experienced CSV.

Validation Engineer III, West-Ward Pharma

IVT’s 19th Annual Computer and Software Validation

Industry's Leader in CSV Excellence

IVT’s 19th Annual Computer and Software Validation is the flagship industry event for CSV training where quality, validation and IT professionals gather to exchange best practices, stay up to date on current and upcoming regulations and take part in hands-on exercises to put the learning into action.

This year’s highlights include a Case Study Showdown to examine organizational experiences of moving to an agile system, a two-part Documents Management track, and a spotlight session featuring an innovative approach to risk management. With more interactive working sessions, case studies and real-life examples than ever before, IVT’s 19th Annual CSV conference is taking validation excellence to new heights.

FDA SPEAKER JUST ANNOUNCED!

Francisco Vicenty, Program Manager, Case for Quality, Office of Compliance, CDRH, U.S. FDA will be joining us at IVT’s CSV Conference next week to share an update on FDA and Industry’s Collaboration on Non-Product CSV.

Mr. Vicenty will be co-presenting with his industry colleagues, Khaled Moussally, Head of Quality Management Systems at Compliance Group and Jason Spiegler, Senior Director, Industry Portfolio Development at Siemens Product Lifecycle Management Software Inc.

Timely Topics!

  • Examine Organizational Experiences Transitioning to an Agile System
  • Where Do We Stand with Data Integrity in 2018? An Update on the Regulatory Landscape
  • Establish GMP Compliant Cloud Software Validation Procedures

Highly Anticipated Breakouts!

  • Create Strategic Alliances between IT and Quality to Achieve Compliance
  • Death by Documents and How to Avoid It
  • Identify and Integrate Best Practices for Maintaining Data Integrity in Emerging Markets

TWO HANDS-ON WORKSHOPS!

  • Establish a Plan for Transitioning to a Cloud-Based Validation Environment led by Holly Baldwin, Senior Validation Advisor, UL Compliance to Performance
  • Conduct a Self-Assessment of Your Data Integrity Effectiveness through the GAMP Data Integrity Maturity Model led by Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

Enhanced Networking Opportunities!

  • Join the “Extra Inning” Networking Reception on Wednesday
  • Convene with conference peers for dinner on Thursday

 

Previous Attendee Acclaim:

This program has helped me be more multi-faceted in my approach and refresh my knowledge base in the industry.

Senior Validation/Calibration Technical, Prometheus

Excellent forum to share good and bad experiences,
areas in common and best practices.

Senior Validation Manager, Medtronic

Training and data integrity are great topics in CSV
and I’m glad I learned more about it.

Validation Engineer 2, Illumina

Great platform to share knowledge and trends
within the industry.

QA Engineering Manager, Agensys

A great networking experience. Lots of great dialogue.

Quality Specialist III, Thermo Fisher

It was great to hear the similar challenges
from folks in the industry.

CSV Engineer, Bachem

While my company has many good practices in place,
this conference gave me insight into current industry
standards and audit focus. I would recommend this
conference to beginner and experienced CSV.

Validation Engineer III, West-Ward Pharma