Event Detail
Project Management for Computer Systems Validation - Webinar By GlobalCompliancePanel
August 29, 2012 - Wilmington DE US
GlobalCompliancePanel
webinars@globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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 - background Causes of Form 483 / Warning Letter Some recent results of companies failing to respond appropriately Best Practices for Responding to 483 Best Practices for Responding to Warning Letter What to do if the responses fail Who Will Benefit: Project Managers IT Management Business Process Owners Quality Managers Quality Engineers GxP Consultants Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world. Price List: Live : $245.00 Corporate live : $495.00 Recorded : $295.00 Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com