Building An Effective GMP Training System: A Risk-Based Approach
With the recent increase of job knowledge deficiencies being cited in regulatory inspections – especially in the areas of data integrity and sterile product manufacturing – training and qualification of personnel is becoming increasingly important to inspectors.
Additionally, agency inspectors are now asking very different – and much more advanced – questions about training, rather than simple questions like “Can you provide me a record that shows this individual was trained on this SOP?” Topics such as instructional design, control of training materials, qualification of trainers, training requirements and competency assessments are common in discussions with inspectors…and are being cited in 483s and warning letters with alarming regularity.
Is your training system up to the challenge? Join us for our 90-minute interactive training course, where you will:
- Learn to define and understand the regulatory expectations around training and training systems
- Identify the required elements of an effective training system – and whether you have them
- Receive an analysis of recent 483 and warning letter observations, and how having an effective training system would have addressed these issues before they became observations
- Learn to assess your own training system: Identify gaps that could lead to inspectional observations
This course will be of benefit to anyone working in a GMP regulated environment (on a global or domestic scale) with responsibility for employee training. This includes personnel involved with providing training, oversight of others who provide training, or the training department in a GMP regulated environment. Quality, validation, manufacturing, management personnel, corporate leadership and front-line trainers will gain specific benefit from attending. Those who are actively involved in performing, overseeing, auditing or managing training as a function or as an operational responsibility will find this course extremely valuable.
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.