Master Planning for Computer System Validation

Instructor: Dr. Ludwig Huber
Product ID: 700106
Training Level: Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

This Computer System Validation training will guide you through Master Planning process.

Why Should You Attend:

Planning is the most important part of computer validation. Having a good plan in place with owners, deliverables and check points makes validation easy.

A master plan increases the efficiency and consistency of validation and answers the inspector’s question: what is your approach towards computer system validation. A master plan is also a requirement of European GMPs. However, despite of this importance, the regulated industry is unsure on how to develop and document such a plan. Using a real example this seminar will guide attendees through the planning process.

What Attendees will Learn:

  • FDA and international requirements
  • Terminology and type of planning: validation master plan, master validation plan, validation project plans
  • Developing an effective validation master plan as a frame work for all validation projects
  • Developing a project plan for individual validation projects
  • Responsibilities
  • Contents and deliverables of a validation master plan and project plan
  • Relationship of master plans to other documents: risk plan, training plan, SOPs
  • Proper execution of the plans
  • Templates and examples

Additional benefits:

Attendees will receive a 53 pages computer system validation example plan with templates for easy implementation.

Note: These complimentary hand-outs will be sent to customers on request. Please email for these documents, stating your order number, and they will be emailed to you within 4 working days.

Who Will Benefit:

  • Everybody involved in software and computer system validation
  • IT Administrators
  • QA managers and personnel
  • Validation specialists
  • Suppliers of software and computer systems
  • Regulatory affairs
  • Training department
  • Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber’s website:

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Product Reviews Write review

The provided documentation was good.
- Anonymous

Information presentations and handouts helpful
- Anonymous

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