Upon analyzing investigation reports, it has been found that deviations, discrepancies and quality incidents in pharmaceutical manufacturing have human error as one of the top root causes. Examining the Corrective and Preventive Action (CAPA) developed from these, retraining and rewriting of SOP are at the top of the list. However, these problems keep resurfacing, the CAPA’s are ineffective. The question that comes up is whether the CAPA’s are wrong or if there is a different problem? The investigation did not pinpoint the root cause of or the most probable contributing factors to the problem. “Human error” is often not really the problem, rather a symptom of a system or facility or operation that is not designed to be run by humans. Human contribution to the problems is most often because they do what is not designed with humans in mind.
So, an effective CAPA, rather than focusing on remediation of people, should be developed to solve the problems with the system, facility and operation. For this to happen, investigations must focus on getting to the root cause and contributing factors.
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. This session, with expert Angela Bazigos, will help you identify if you are too quick to ascribe guilt to people rather than probe deeper. She will focus on discussing improved techniques that will get to the real cause of the problem. This will help you to develop meaningful CAPAs that can remedy these problems, the first time.
This session will also focus on how to assess the success of these CAPA's. Successful CAPAs reduce repeat observations significantly, which further leads to improved efficiency and operations that are right the first time. This live interactive presentation will also discuss the regulations associated with detecting, correcting and preventing human errors in GMP manufacturing and laboratory processes.
Who should attend
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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