Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
May 23, 2012
Location
Online Event
2600 E. Bayshore Road
Palo Alto, California 94303
USA
Description
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.
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.
Organized by
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, California 94303
United States of America
More Information
Contact: Referral
Email: referral@complianceonline.com
Phone: +1-650-620-3915
Event's Website
