"What to do if you get a FDA 483 Warning Letter"
Live Webinar on What to do if you get a FDA 483 Warning Letter Date & Time: Thursday, March 29, 2012 10:00 AM PDT | 01:00 PM EDT Register Now Duration: 90 Minutes Instructor: Angela Bazigos Location: Online Price : $245.00 (for one participant) Instructor Profile: Overview: Angela Bazigos Audits by the FDA are perhaps the most intimidating of all events at CEO, Touchstone a regulated facility. Each year, the FDA conducts several thousand Technologies Silicon Valley audits, approximately half of which lead to findings that result in Form 483s. Angela Bazigos is the CEO of Touchstone Technologies Silicon Most Form 483 audits are amicably resolved, but a few lead to Valley, Inc. an FDA Compliance serious consequences for the audited parties, starting with Warning company. She has almost 30 years experience in the Lifesciences Letters and ending with heavy fines and jail time for a few. industry and has applied for patents aimed at speeding up Software This webinar, will assist you in responding to a 483 or Warning Compliance. She is a member of the Letter so the consequences of the findings do not escalate beyond SQA CVIC (Society of Quality the current status. Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Areas Covered in the Session: Computer Systems Validation, Compliance Strategy and Project l FDA Inspections - background Management. More recently, Ms. Bazigos was selected to co-author l Causes of Form 483 / Warning Letter Computerized Systems In Clinical l Some recent results of companies failing to respond Research / Current Data Quality and appropriately Data Integrity Concepts with FDA, l Best Practices for Responding to 483 DIA and Academia. ...more l Best Practices for Responding to Warning Letter l What to do if the responses fail Suggest a Topic More Webinars Click here to register for this webinar Your Necessity is our Priority Who Will Benefit: l CEO l Regulatory VP l Quality VPs l IT VPs l Regulatory Affairs professionals l Quality Managers l Quality Engineers l Small business owners 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