Have you ever had a deviation occur that forced you to retrain staff, had a similar deviation appear, then correct it with another round of the same training on the same procedure? Have you ever taken significant steps to correct an issue, just to see it recur? If you answered “yes” to either of these questions, then chances are your root cause analysis efforts need improving.
Root cause identification is an expectation of FDA and other regulatory agencies, and is one of the most frequently cited problems during regulatory inspections. Many companies do not understand the difference between direct causes and root causes of issues, which lead to weak, inappropriate, or ineffective corrective and preventative actions (CAPAs). Even more companies understand the differences, but are not using an effective process that enables success.
This session will demonstrate an effective investigation and root cause analysis process, and will provide very simple tools that help you identify the true cause of any issue and identify and implement more robust corrective actions. A true case study will be used to illustrate the difference between what does and what should happen.
Take home benefits from this session will include:
This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale. This includes quality, validation, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.
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.
Joanna has held positions in quality assurance, laboratory and training roles. 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 and possesses highly efficient analytical problem solving and root cause analysis skills, which she uses to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness. She has demonstrated the ability to drive culture change and accountability through training and to inspire change and continuous improvement at the operator level as well as through management. Joanna has successfully represented the training function to regulators from around the world, and quickly develops a positive rapport with auditors.
Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, regulatory requirements, and interactive training design. She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was invited 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.