Live Webinar
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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
Duration: 90 Minutes
Instructor: Angela Bazigos
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Angela Bazigos CEO, Touchstone Technologies Silicon Valley
Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.
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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
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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. ...more
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