The Hitchhiker's Guide to 483s and Warning Letters

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Duration: 120 Minutes

Name : Angela Bazigos

Product ID : 500052

Description:

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.

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.

Objectives of the Presentation:

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

Who can Benefit:

CEO
Regulatory VP
Quality VPs
IT VPs
Regulatory Affairs Professionals
Quality Managers
Quality Engineers
Small Business Owners
GxP
Consultants

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Instructor Profile:

Angela Bazigos is an Angel Investor and the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years’ experience in the Life Science industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life Sciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

More recently, Ms Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life Science industry.