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21 CFR Part 11 Compliance 2012 - 2-day In-person Seminar: Computer System Validation - Reduce Costs and Avoid 483s

Date2012-04-27

Deadline2012-04-26

VenueHilton New, USA - United States USA - United States

KeywordsFDA; 21 CFR Part 11; Avoid 483; Warning Letters.; SOPs; software product features; validation documentation; IT infrastructure; COTS Computer System Validation; "Risk-Based Software Validation

Websitehttp://www.complianceonline.com/ecommerc...

Topics/Call fo Papers

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.


This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.


Who will Benefit
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.
- Regulatory Affairs
- QA/ QC
- IT/IS
- Software Managers
- Project Managers
- Software vendors and suppliers

Last modified: 2012-03-28 17:28:20