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Validity : 14th Apr'24 to 24th Apr'24
Identification, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory
- Identify why human error is often designated the root cause of deviations and discrepancies
- Identify why your CAPAs 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
Overview of the webinar
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 CAPAs 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 CAPAs are ineffective. Does it mean that the CAPAs 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.
Who should attend?
- 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
Why should you attend?
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this session, 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 CAPAs. 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.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.