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The webinar titled 'Root Cause Analysis of Human Error in GMP Environments' is organized by ComplianceIQ and aims to equip GMP professionals with essential skills and tools for analyzing and preventing human errors, which are prevalent challenges in Good Manufacturing Practice (GMP) settings. The session will delve into the definition
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and types of human errors, common misconceptions, and regulatory expectations from agencies such as the FDA, EMA, and MHRA. It emphasizes the importance of structured Root Cause Analysis (RCA) as a means to address these errors effectively.
Participants will explore various aspects of human error, including its contributing factors such as training gaps, environmental distractions, and organizational culture. The training will provide a comprehensive overview of key RCA principles, common tools and techniques such as Failure Mode and Effects Analysis (FMEA) and Human Error Taxonomy, along with practical exercises like the 5 Whys and Fishbone Diagram. A case study on real-world GMP compliance violations will facilitate an interactive exercise where attendees will have the opportunity to apply RCA tools and engage in group discussions to derive findings and solutions. The emphasis will be on designing effective corrective and preventive actions (CAPAs) that go beyond just retraining, advocating for system-based corrections and fostering a culture of quality and accountability within organizations.
Through this 90-minute online workshop, participants will learn to identify and classify different types of human errors—such as slips, lapses, mistakes, and violations—by understanding their procedural, environmental, and organizational influences. They will also examine proactive human error prevention strategies, including error-proofing procedures, SOP simplification, and enhanced training methodologies. The goal is to help GMP professionals not only to comply with regulations but to improve operational efficiency and product quality by driving sustainable error reduction initiatives. The session is particularly beneficial for individuals in roles such as Quality Assurance, Quality Control, Regulatory Affairs, Compliance & Auditing, Production & Manufacturing, Process Development, Engineering & Maintenance, Learning & Development, Human Resources, and others involved in GMP environments. By concluding this training, participants will be prepared to instigate a shift from blame-based approaches to a proactive mindset that focuses on continuous improvement and accountability, increasing the overall resilience of their organizations against human errors.
Participants will explore various aspects of human error, including its contributing factors such as training gaps, environmental distractions, and organizational culture. The training will provide a comprehensive overview of key RCA principles, common tools and techniques such as Failure Mode and Effects Analysis (FMEA) and Human Error Taxonomy, along with practical exercises like the 5 Whys and Fishbone Diagram. A case study on real-world GMP compliance violations will facilitate an interactive exercise where attendees will have the opportunity to apply RCA tools and engage in group discussions to derive findings and solutions. The emphasis will be on designing effective corrective and preventive actions (CAPAs) that go beyond just retraining, advocating for system-based corrections and fostering a culture of quality and accountability within organizations.
Through this 90-minute online workshop, participants will learn to identify and classify different types of human errors—such as slips, lapses, mistakes, and violations—by understanding their procedural, environmental, and organizational influences. They will also examine proactive human error prevention strategies, including error-proofing procedures, SOP simplification, and enhanced training methodologies. The goal is to help GMP professionals not only to comply with regulations but to improve operational efficiency and product quality by driving sustainable error reduction initiatives. The session is particularly beneficial for individuals in roles such as Quality Assurance, Quality Control, Regulatory Affairs, Compliance & Auditing, Production & Manufacturing, Process Development, Engineering & Maintenance, Learning & Development, Human Resources, and others involved in GMP environments. By concluding this training, participants will be prepared to instigate a shift from blame-based approaches to a proactive mindset that focuses on continuous improvement and accountability, increasing the overall resilience of their organizations against human errors.
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Timings09:00 AM-06:00 PM (expected)Not Verified | Entry FeesCheck Official Website |
Estimated Turnoutupto 100 Delegates Based on previous editions | Event TypeWorkshop |
EditionsMar 2025+1 more edition Frequency Monthly Next edition likely in Apr 2025 | Official LinksWebsiteContacts Report Error Claim this event |
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ComplianceIQ USA1552 Total Events • 540 Followers | |
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