Computer System Validation in FDA-regulated Industries


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This 2-day seminar includes an overview of validation tasks required by FDA Regulations and Guidelines. The course content goes beyond simply “what” needs to be done – the emphasis is on “how” to accomplish computer system validation tasks. The workshop format promotes hand-on, practical learning. Participants learn:

  • A Validation Process that addresses Regulatory Requirements and Guidelines for Computer System Validation
  • Regulatory action taken for non-compliance to Validation Requirements (483s & Warning Letters)
  • Risk Management Activities
  • How to develop and execute a Validation Plan
  • How to perform and document Validation Tasks
  • How to assess Software Development Activities for various types of software, and the impact of the development activities on the validation process
  • How to develop, complete, and document Test Activities
  • How to summarize, assemble, package, and maintain validation Documentation

The Registration Fee includes attendance both days, continental breakfasts, lunches, and breaks, an attendee binder containing slides, handouts, and activities, and 30 minutes of follow-up validation consulting.

Additional information

Dates Offered:

May 02-03, 2017 Feasterville, PA, November 07-08, 2017 Feasterville, PA

Seminar Agenda – Day 1

  • Introduction
    • Session Agenda & Goals
    • Participant Introductions
  • Validation Overview
    • Key Validation Terminology
    • Reasons and Motivations for addressing Validation
    • Validation Mind Set Activity
  • Validation Process
  • Validation Plan
    • Contents
    • Developing the Plan Activity


  • Risk Management
    • Assessment
    • Mitigation
  • System Development
    • Alternative Life Cycle Methodologies
    • Deliverables
    • Standards
    • Assessing development activities
  • System Installation
  • Testing
    • Phases
    • Process
    • Test Types & Tools
Seminar Agenda – Day 2

  • Day 1 Recap – Questions & Answers, Day 2 Plan
  • Introduction to a Computerized System (used during the Activities)
  • User Acceptance Test Plan
    • Contents
    • Techniques for Plan Development
  • Plan Development Activity
  • Test Scripts
    • Development & Execution
    • Report Evaluation Activity
  • Security Issues Activity
  • Traceability Analysis/Traceability Matrix


  • Validation Report
  • Validation File Documentation Activity
  • Tailoring the Validation Process
  • Change Management
  • Regulatory Impact
    • FDA Regulatory Requirements for Validation
    • Guidance Documents
    • Regulatory Actions for Non-compliance
    • 483 Activity
  • Wrap-up