Qualifying Your Trainers – What Do They Need For Your Training To Be Effective?
In a GMP environment, the training process is the critical foundation of your business. You need qualified, competent people to perform your operations, and that happens through the people you select as trainers. The people you have providing training – on the floor or in the classroom – can make or break your training program. So what can you do to ensure the right people are providing training? What skills do they need to be successful as a trainer?
Even if you have the right people with the right skills, you’re still only halfway there. There are a few other things they need – and without them, the training they provide won’t be effective.
If you’d like to start making your organization’s training more effective – and seeing the results of more effective training in your quality system – start here. This course will provide a step-by-step foundation for identifying what an effective training system must include, identifying the right personnel to conduct training, understanding training design, and measuring outcomes.
Take home benefits from this session will include:
- Identifying required elements of an effective training system – and whether you have them
- Understanding the “paradox of training” and how it impacts the success of training
- Defining the skills and abilities trainers need to be successful – some of which you can teach and some you can’t
- Understanding the role of instructional design – the least understood and most overlooked element of training – and how it provides benefits to your quality system
- Identifying what gets in the way of a trainer providing effective training
- Defining the regulatory expectations for training, and what is required to meet them
- Guidance for assessing your organization’s process and for assessing level of compliance with other regulatory expectations
This course will be of benefit to anyone working in a GMP regulated environment on a global or domestic scale, having responsibility for training - including providing training, overseeing others who provide training, or for the training department in a GMP regulated environment. This includes quality, validation, manufacturing and management personnel, leadership and trainers. 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 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.