Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
Instructor:
Dr. Ludwig Huber
Product ID: 702303
- Duration: 75 Min
Why Should You Attend:
When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems.
This web seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective implementation.
Learning Objectives:
- Definition of legacy systems and retrospective validation.
- FDA requirements and inspection practices.
- Examples of FDA warning letters.
- Industry recommendations, e.g., from the GAMP.
- Assessment activities, e.g., gap analysis and risk assessment.
- Reviewing and updating the validation master plan for existing systems.
- Going through the validation lifecycles from planning to ongoing tests in routine use.
- Documenting validation results for FDA/EU compliance.
- Dealing with requirements for electronic records/signatures: Part 11, New Annex 11.
Who will Benefit:
- IT managers and system administrators
- QA managers and personnel
- QC and Lab managers
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
Dr. Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: www.ludwig-huber.com
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