Course Description:
Attention, memory and decision making errors are directly associated with cognition overload and mistakes. This course explores the human mind, human factors and cognitive overload in GMP related environments.
Through a combination of discussion and interactive exercises attendees will learn:
How to Perform a Cognitive Load Assessment. Participants will begin the course by learning how to perform a cognitive load assessment to reduce errors. Attendees will also be provided examples of poor human factor, engineering and workplace conditions that contribute to errors.
Human Error Reduction Techniques. Participants will be taught how and when to apply engineering controls to correct and prevent errors. Participants will work with fellow attendees to create and analyze results through the use of a box plot chart.
Human Error Investigation. Participants will be taught the proper steps to take for an effective human error investigation from beginning to end. They will be taught how to gather data when analyzing cognitive load. They will also be taught how to perform an effective interview and how to properly report issues to management in a way that they will listen
Through the use of a case study participants will conduct a full cognitive load assessment including a root cause analysis and CAPA development plan.
COMPLEMENTARY COURSE BINDER MATERIALS (Value US$ 549.00)
- Root cause determination tool
- Interviewing guide – you can take back and use immediately
- Example of well-documented HE report
- Complete copy of slide deck materials
- Copies of applicable FDA regulations referenced in the course
- Copies of pertinent FDA guidance documents
- Articles focused on human error reductions
Seminar Fee Includes:
Who will Benefit:
- QA/QC directors and managers
- Process improvement/excellence professionals
- Training directors and managers
- Manufacturing operations directors
- Human factors professionals
- Plant engineering
- Compliance officers
- Regulatory professionals
- Executive management
Course Outline:
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM 9:00 a.m. – 10:00 a.m.
10:00 a.m. – 10:15 a.m. 10:15 a.m. – 12:00 p.m.
12:00 p.m. – 1:00 p.m. 1:00 p.m. – 4:30 p.m.
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8:30 a.m. – 10:00 a.m.
Interactive Exercise: Creating and analyzing results. Create and export the Box Plot Chart 10:00 a.m. – 10:15 a.m. 10:15 a.m. – 12:00 p.m.
12:00 p.m. – 1:00 p.m. 1:00 p.m. – 2:30 p.m. 2:30 p.m. – 2:45 p.m. 3:00 p.m. – 4:00 p.m.
4:00 p.m. – 4:30 p.m.
4:30 p.m. |
Meet Your Instructor
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Ginette M Collazo Industrial/Organizational Psychologist at Ginette M. Collazo GINETTE COLLAZO, PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics. |
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