The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 24, 2022 from 10am to 1pm
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: webinar
Organized By: ComplianceOnline
Latest Activity: Feb 1, 2022
This instructor-led live training webinar will discuss regulatory requirements for detecting, correcting and preventing human errors in manufacturing and laboratory environments as well as developing a competent, effective corrective and preventive action system.
Why Should You Attend:
Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's are ineffective. Does it mean that the CAPA's were wrong or is it pointing to another problem? Namely, that the investigation did not pinpoint the root cause of or most probable contributing factors to the problem. Most often "human error" is not really the problem but a symptom of a system or facility or operation that is not designed to be run by humans. Humans do contribute to problems but more often than not, because what we are asking them to do is not designed with humans in mind. So a true CAPA should be developed to solve the problems with the system, facility and operation rather than focus on remediation of people. This requires investigations to focus on getting to the real root cause and contributing factors.
Areas Covered in the Webinar:
Who Will Benefit:
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