Updated October 26, 2022
You might also be interested in this course offering.
This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization.
Pricing | Questions? - Call us: (415) 948-5220
How This Course Is Implemented
This course is implemented in three phases: Awareness, Certification, and Master Trainer. This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.
- GMP Trainer Awareness – Students view presentations covering the course objectives below.
- GMP Trainer Certification – Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.
- GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.
In this course, you will learn how to:
- Apply a Participant Centered Approach to training
- Write course objectives
- Development a course assessment
- Describe the difference between ice breakers and activities
- Describe and develop ice breakers for a class
- Describe and develop activities for a class
- Explain the role of the instructor during activities
- Develop an activity debriefing strategy
- Describe various strategies for forming groups
- Design a course presentation
- Identify and demonstrate effective presentation skills
- Develop stories for a class and how to deliver the story
- Develop discussion questions
- Develop and implement discussion follow-up strategies
- Demonstrate the management of disruptive behavior
- Identify the elements of a course assessment validation plan
- Identify the elements of a course evaluation form
- Develop a course evaluation form
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Trainers must be skilled!
- They must be expert course designers and facilitators
- They must pay attention to the experiential learning process
- They must keep students involved, engaged, and energized
It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.
GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.
What does that mean?
It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.
Expert GMP & QSR trainers:
- Focus on experiential learning processes
- Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
- Design and facilitate learning activities
- Facilitate meaningful discussions, and create safe environments through the debrief process
- Model different teaching strategies
- Tell compelling case stories
- Keep students involved, engaged, and energized
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