Responding to FDA 483s and FDA Warning Letters - Can you afford not to be prepared?

Product Id : FDA137
Instructor : Angela Bazigos
Aug 01, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Overview

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.

A fun way to present this serious topic!! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility.

483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared?

In this webinar you will learn How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters, How to respond to 483s and Warning Letters to avoid escalation by the FDA.

Areas Covered in the Session:

  • Why the FDA issues such citations
  • What is a 483 and what does it look like
  • What is a Warning letter and what does it look like
  • What is the difference between a 483 and a Warning Letter
  • What they mean for your company
  • How to respond to 483s and Warning Letters to avoid escalation by the FDA
  • How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters

Who Will Benefit:

  • CEO
  • Regulatory Professionals
  • Quality Professionals
  • Regulatory Affairs Professionals: Quality Managers, Quality Engineers, Small Business Owners, GxP Consultants
Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer : http://morflearning.com/angelabazigos/, Director of QA and MIS Director.  Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA & DIA:

http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom : http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/

Includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents,Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview  


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