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Driven by the Regulatory Expectation of Today and the Technologies of Tomorrow

April 23-25, 2019
  • San Diego, CA

Cloud Computing Agile Environment
Risk-Based Approaches Data Integrity

As the leading forum for computer systems training, IVT’s 20th Annual Computer and IT Systems Validation conference connects you with subject matter experts in IT, quality, agile systems, data integrity and validation. Gain insight on the most complex CSV challenges from managing SaaS and cloud validations to implementing a comprehensive data governance program and gain tips on what to look for during your next FDA inspection.

Backed by two decades of educational excellence, IVT’s CSV conference is a proven venue for knowledge exchange and valuable hands-on learning. The 20th annual event features three content streams to meet the educational requirements of your entire team, from the newest validation engineer to the VP of Quality.

Special Conference Features

A. CIO Address
Engaging the Age of Digital Transformation in Life Sciences – Drive Technology Development through a Culture of Quality.

B. TOWN HALL SESSION
Participate in an Exclusive Industry Benchmarking Opportunity to Identify Gaps in Regulatory Guidance.

C. Regulatory Insights
Analysis of FDA’s recently released final Data Integrity and Compliance with Drug CGMP Guidance

D. TWO INTERACTIVE WORKSHOPS

  • Cloud Computing and Cloud Validation Masterclass
  • Managing Computer Systems Controls
Benefit from Three Content Streams
1. Advanced Leadership including topics on:
  • Advanced Collaborative Session – Strategies for Communicating CSV Business Needs to Executive Leadership
  • SaaS Validation Roundtable — Navigating the Challenging Single and Multi-Tenant SaaS Landscape
  • Apply CSV Concepts to Validate New Manufacturing Technologies
2. Technical Practice including topics on:
  • Master the Validation of Data Analytics Platforms, Programs and Data Infrastructure
  • Risk-Based Computer Systems Validation – A Holistic Model
  • Prepare for FDA Audits and Inspections – The Ultimate CSV Handbook
3. Data Management including topics on:
  • Utilize a Lifecycle and Risk-Based Approach to Streamline the CSV Process for Clinical Trial SaaS
  • Migrate GxP Document and Quality Management Systems
  • Create Your Own Go-To Guide for GXP Systems Compliance – Documents, SOPs, Change Control and Audit Trails

Previous Attendee Acclaim:

I was impressed with the quality of the presenters, very knowledgeable and so down to earth, that by sharing their experiences make you feel, “you're not alone.”
You will learn a lot!

CSV Analyst, Arthrex

I really enjoyed the presentations and getting updated with what is happening in the industry. The best part is to hear
from the FDA and their thoughts on validation.

Senior Validation Specialist, Celgene Corporation

The conference was a great opportunity to get new ideas
and to talk to other experts.

Head CSV, QS Trainings Management, Sanofi

Extremely organized and informative sessions. Each speaker encouraged questions and an open discussion.
Highly recommend!

IT Project Manager, Rhodes Pharmaceuticals

Really great conference with a lot of helpful content to
refine our validation program.

Computer Software Validation Coordinator, Provident Nutraceuticals

20th Annual Computer and IT Systems Validation

Driven by the Regulatory Expectation of Today and the Technologies of Tomorrow

Cloud Computing Agile Environment
Risk-Based Approaches Data Integrity

As the leading forum for computer systems training, IVT’s 20th Annual Computer and IT Systems Validation conference connects you with subject matter experts in IT, quality, agile systems, data integrity and validation. Gain insight on the most complex CSV challenges from managing SaaS and cloud validations to implementing a comprehensive data governance program and gain tips on what to look for during your next FDA inspection.

Backed by two decades of educational excellence, IVT’s CSV conference is a proven venue for knowledge exchange and valuable hands-on learning. The 20th annual event features three content streams to meet the educational requirements of your entire team, from the newest validation engineer to the VP of Quality.

Special Conference Features

A. CIO Address
Engaging the Age of Digital Transformation in Life Sciences – Drive Technology Development through a Culture of Quality.

B. TOWN HALL SESSION
Participate in an Exclusive Industry Benchmarking Opportunity to Identify Gaps in Regulatory Guidance.

C. Regulatory Insights
Analysis of FDA’s recently released final Data Integrity and Compliance with Drug CGMP Guidance

D. TWO INTERACTIVE WORKSHOPS

  • Cloud Computing and Cloud Validation Masterclass
  • Managing Computer Systems Controls
Benefit from Three Content Streams
1. Advanced Leadership including topics on:
  • Advanced Collaborative Session – Strategies for Communicating CSV Business Needs to Executive Leadership
  • SaaS Validation Roundtable — Navigating the Challenging Single and Multi-Tenant SaaS Landscape
  • Apply CSV Concepts to Validate New Manufacturing Technologies
2. Technical Practice including topics on:
  • Master the Validation of Data Analytics Platforms, Programs and Data Infrastructure
  • Risk-Based Computer Systems Validation – A Holistic Model
  • Prepare for FDA Audits and Inspections – The Ultimate CSV Handbook
3. Data Management including topics on:
  • Utilize a Lifecycle and Risk-Based Approach to Streamline the CSV Process for Clinical Trial SaaS
  • Migrate GxP Document and Quality Management Systems
  • Create Your Own Go-To Guide for GXP Systems Compliance – Documents, SOPs, Change Control and Audit Trails

Previous Attendee Acclaim:

I was impressed with the quality of the presenters, very knowledgeable and so down to earth, that by sharing their experiences make you feel, “you're not alone.”
You will learn a lot!

CSV Analyst, Arthrex

I really enjoyed the presentations and getting updated with what is happening in the industry. The best part is to hear
from the FDA and their thoughts on validation.

Senior Validation Specialist, Celgene Corporation

The conference was a great opportunity to get new ideas
and to talk to other experts.

Head CSV, QS Trainings Management, Sanofi

Extremely organized and informative sessions. Each speaker encouraged questions and an open discussion.
Highly recommend!

IT Project Manager, Rhodes Pharmaceuticals

Really great conference with a lot of helpful content to
refine our validation program.

Computer Software Validation Coordinator, Provident Nutraceuticals