RAPS Approved Webinar
Avoiding 483 Warning Letters & Remediation if you get one
Date & Time: Course "Avoiding 483 Warning Letters & Remediation if you get
one" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Instructor Profile: Wednesday, August 8, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Angela Bazigos
Price : $245.00
Angela Bazigos CEO, Touchstone Technologies Silicon Valley
(for one participant)
Overview: 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.
Areas Covered in the Session: l l l
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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
Click here to register for this webinar
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. ...more
Who Will Benefit: l
IT Management Business Process Owners
Quality Managers Quality Engineers GxP
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Published on Aug 7, 2012
Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several tho...