Overview: Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market. This class, will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements. Areas Covered in the Session:FDA Inspections - backgroundCauses of Form 483 / Warning LetterSome recent results of companies failing to respond appropriatelyBest Practices for Responding to 483Best Practices for Responding to Warning LetterWhat to do if the responses failWho Will Benefit:Project ManagersIT ManagementBusiness Process OwnersQuality ManagersQuality EngineersGxP ConsultantsAngela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. USAGlobalCompliancePanel,Livermore Common, Fremont, CA, 94539USA Phone:800-447-9407Fax: 302-288-6884