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Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.
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.
For easy implementation, attendees will receive
- SOP: Retrospective Validation of Computerized Systems
- Checklist: Retrospective Validation of Computer Systems
Note: These complimentary hand-outs will be sent to customers on request. Please email firstname.lastname@example.org for these documents, stating your order number, and they will be emailed to you within 4 working days.
- 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
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
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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Dr. Ludwig Huber
Understanding and Implementing USP <1058>: Analytical Instrument Qualification Change Control for Computer Systems - strategies and tools for FDA compliance Master Planning for Computer System Validation Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation