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.
RAPS Approved Webinar on Project Management for Computer Systems Validation Date & Time: Course "Project Management for Computer Systems Validation" has been pre-approved by RAPS as eligible for up to 1.5 credits Register Now towards a participant's RAC recertification upon full completion. Instructor Profile: Wednesday, August 29, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: Angela Bazigos Angela Bazigos CEO, Touchstone Location: Online Price : $245.00 (for one participant) Technologies Silicon Valley Angela Bazigos is the CEO of Overview: Touchstone Technologies Silicon Valley, Inc. an FDA Compliance Per the CDRH, 20% of product recalls in the medical device industry company. She has almost 30 years are due to faulty software!!! Yet, these human, financial and experience in the Lifesciences industry and has applied for patents reputation capital expensive issues, can be averted with aimed at speeding up Software computerized systems validation and 21 CFR 11 compliance. The Compliance. She is a member of the Project Manager for a Validated Computerized System, has to deliver SQA CVIC (Society of Quality on time and on budget, but with the added risk of having to meet Assurance Computer Validation regulatory compliance, often causing project overruns, regulatory Initiative Committee), DIA and RAPS findings and missed times to market. and teaches classes on 21 CFR 11, Computer Systems Validation, This class, will explain the basic tenets of project management, the Compliance Strategy and Project Management. More recently, Ms. basic tenets of 21 CFR 11 compliance for Computer Systems Bazigos was selected to co-author Validation and will show how to marry the two, to deliver on time Computerized Systems In Clinical and on budget while meeting regulatory compliance requirements. Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. Areas Covered in the Session: Angela Bazigos has been accepted l FDA Inspections - background into the prestigious ranks of Stanford l Causes of Form 483 / Warning Letter Who's Who as a result of her l Some recent results of companies failing to respond remarkable work in the biotechnology industry. Throughout appropriately her brilliant professional career, l Best Practices for Responding to 483 Angela has routinely exhibited the l Best Practices for Responding to Warning Letter passion, vision and dedication l What to do if the responses fail necessary to be successful in the business world. ...more Click here to register for this webinar Who Will Benefit: Suggest a Topic More Webinars Your Necessity is our Priority l Project Managers l IT Management l Business Process Owners l Quality Managers l Quality Engineers l GxP l Consultants It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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