Master Planning for Computer System Validation
Instructor:
Dr. Ludwig Huber
Product ID: 700106
Training Level: Advanced
- Duration: 60 Min
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
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
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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