Human error. It is one of the most frequently-cited root causes during investigations, which is ironic, because the proper conclusion is rarely human error. Regulatory agencies globally understand this but, unfortunately, most firms don't.
Global regulators have increased their focus on deviations and root cause analysis (RCA), and this process is one of the largest sources of inspection observations. Frequently identifying “Human Error” as a root cause and “Retraining” as a CAPA is a clear indication to the regulatory authorities that you’re not solving the quality issues and related problems that exist in your organization. Worse, it can give regulators the impression that your staff is ill-prepared, error prone, AND you don't have a handle on the real causes of your deviations.
In this interactive webinar, we’ll explore a collection of conditions that can contribute to human error – including identifying the ONE condition where retraining may actually help.
Attendees will learn:
Attend this course and receive:
This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale who is charged with identifying and addressing sources of human error in GMP operations. This includes leadership, management, and other personnel in quality, manufacturing, engineering, and other regulated functions. This course will be of particular interest to those managing, leading and/or working in a training function.
Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments. Over her career she has provided regulatory, technical, skill and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management.
Over her career, she has held positions in quality assurance, laboratory and training roles, which enables her to translate operational experience into training. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result. She is well versed in instructional systems design, problem solving and root cause analysis skills, and she uses these skills to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.
Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, and interactive training design. She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was asked to join the GMP TEA, Inc. Board of Directors in 2008. She is one of the founders of and an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.