Master Planning for Computer System Validation

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.

• 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.

• 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