Webinar On “Project Management for Computer Systems Validation” from GlobalCompliancePanel
03/07/2013

An FDA audit is perhaps a regulatory facility’s worst nightmare. Nearly one in every two of the thousands of audits the FDA conducts across the length and breadth of the country results in issuance of 483.

Online PR News – 07-March-2013 – Fremont – Description:
An FDA audit is perhaps a regulatory facility’s worst nightmare. Nearly one in every two of the thousands of audits the FDA conducts across the length and breadth of the country results in issuance of 483. Although many 483s are resolved harmoniously; punishments ranging from warning letters penalties to jail terms are handed out to many companies, depending on the severity of the violations.
The old adage, “prevention is better than cure”, applies to this situation. The manufacturing facility has to take steps that prevent inviting a 483. This webinar will familiarize participants with what steps to take in order to prevent a 483. It will help participants respond to it if it is issued, so that these steps make sure that matters do not escalate.
At the end of this session; participants will have learnt Best Practices for responding to 483s and Warning Letters, and more importantly, what to do if the response fails.
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When:March 14, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years’ experience in the Life Sciences 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 conducts 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.
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For whom:
The webinar will benefit
o Project Managers
o IT Management professionals
o Business Process Owners
o Quality Managers
o Quality Engineers
o GxP professionals
o Consultants
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Duration:90 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407