ComplianceOnline

Master Planning for Computer System Validation

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

recorded version

$249.00
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

$500.00
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: +1-650-963-2556

Email: customercare@complianceonline.com

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 customercare@complianceonline.com 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 www.labcompliance.com, 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: www.ludwig-huber.com

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Product Reviews Write review

The provided documentation was good.
- Anonymous

Information presentations and handouts helpful
- Anonymous

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