By : Compliance Online
Date : 2012
Location : California / Palo Alto
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.
Legacy Systems, Computer System Validation, CSV, FDA Compliance, EU Compliance
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.
Who will Benefit:
- IT managers and system administrators
- QA managers and personnel
- QC and Lab managers
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
- 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.
Instructor :- 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
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria