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The Trainer
Dr. Ludwig Huber
Compliance Program Manager, Agilent Technologies |
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Venue and Date
New Delhi - March 21, 2007
Time:
10:00 am - 5.30 pm |
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Training Seminar on Computer System Validation and Part 11 Compliance in Practice
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “Training Seminar on Computer System Validation and Part 11 Compliance in Practice” by Dr. 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
Outline of Conference
| MORNING SESSION - 10:00 AM - 1:30 PM |
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Current and Future Requirements Part 11
- Part 11 requirements under the narrow scope
- FDA Inspection and enforcement practices: Recent warning letters
- The future of Part 11: Learn what's coming and how to implement
- Six essential steps to implement a Part 11 program
- Formal justification and documentation for the FDA and your management
Cost Effective Computer System Validation
- FDA expectations and enforcement
- Recent warning letters and how to avoid them
- Developing an effective computer system validation program
- What's important for planning, specifications, IQ/OQ/PQ, changes
- What to do with networks and Excel
- Reduce costs through risk based validation
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Frequently the real problem comes after the seminar: where to start, how to start, and how to implement and document. Not so with this seminar. Attendees will get a suite of tools that will help to quickly implement what they have learned.
They include:
- SOPs for Part 11 implementation and computer validation
- Checklists for Part 11 and computer validation
- Validation examples
- Video presentation: Preparing your organization for the new Part 11
- Frequently asked questions and answers from the seminar
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| AFTERNOON SESSION - 2:30 PM - 5:30 PM |
- Which system should comply with Part 11
- Which requirements should be implemented
- How to implement different Part 11 requirements
- How much to validate and test for high/medium/low risk systems
- How to best justify and document your decision
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