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Build a Robust, Compliant and Agile CSV Program in a Rapidly Changing Environment

April 25-27, 2018
  • Philadelphia, PA

IVT’s 19th Annual Computer and Software Validation is the flagship industry event for CSV excellence where quality, validation and IT professionals gather to exchange best practices, stay up to date on current regulations and what they mean for the industry and share proven strategies for a compliant and agile CSV program.

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.

2018 Featured Topics Include:

  • In-depth review of 483 letters related to CSV non-compliance
  • Conduct a cohesive gap analysis for your CSV program
  • How does the Mutual Recognition Agreement affect inspections?
  • Survivor’s Guide to a Regulatory Inspection of CSV and Data Integrity
  • Understand and implement cloud qualification programs
  • Best practices for transitioning to an agile software development model in a regulated environment
  • Achieve validation integration between CSV and equipment
  • Explore innovative COTS validation approaches
  • Conduct thorough risk assessments and establish appropriate
    CAPAs and remediation activities
  • Evaluate and improve emergency change control procedures
  • Learn from common mistakes and misconceptions for validation

Download the Agenda at a Glance

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

Build a Robust, Compliant and Agile CSV Program in a Rapidly Changing Environment

IVT’s 19th Annual Computer and Software Validation is the flagship industry event for CSV excellence where quality, validation and IT professionals gather to exchange best practices, stay up to date on current regulations and what they mean for the industry and share proven strategies for a compliant and agile CSV program.

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.

2018 Featured Topics Include:

  • In-depth review of 483 letters related to CSV non-compliance
  • Conduct a cohesive gap analysis for your CSV program
  • How does the Mutual Recognition Agreement affect inspections?
  • Survivor’s Guide to a Regulatory Inspection of CSV and Data Integrity
  • Understand and implement cloud qualification programs
  • Best practices for transitioning to an agile software development model in a regulated environment
  • Achieve validation integration between CSV and equipment
  • Explore innovative COTS validation approaches
  • Conduct thorough risk assessments and establish appropriate
    CAPAs and remediation activities
  • Evaluate and improve emergency change control procedures
  • Learn from common mistakes and misconceptions for validation

Download the Agenda at a Glance

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