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CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

November 1 @ 10:00 am - 11:30 am

We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper.

We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time. We will focus on how to assess the success of these CAPA’s. This will lead to a significant reduction of repeat observations which will lead to improved efficiency and right first time operations. This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.

Areas Covered in the Session: Identify why human error is often designated the root cause of deviations and discrepancies Identify why your CAPA’s are less effective than you hoped Understand why human error is not the real cause of the deficiencies and deviations How to probe further to identify the causes or contributing factors that really cause the problems you are seeing How to develop a true CAPA for these problems Develop an efficient and effective CAPA system to remedy the ingrained problems Identification and prevention of human error during data entry Most common GMP issues caused by human error during laboratory and manufacturing processes Who Will Benefit: Quality Assurance Personnel Quality Control Personnel Supply Chain and Logistics Managers Regulatory Affairs Professionals Process Development Scientists and Management Manufacturing Management and Scientists Project Managers working in the CMC arena 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.


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