Building GMP Excellence: A Guide to Implementing Compliant Training Programs
The session discussed GMP regulations, agency expectations, training program responsibilities, new employee requirements, transferred employees, external service providers, events, skills qualification program, assessment, retraining, instructor qualifications, curriculum, documentation, and performance deviations.
Tuesday, May 28, 2024
10:00 AM PDT | 01:00 PM EDT
90 Minutes
More Trainings by this Expert Product Id : 506003
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Even though the training is considered the “vaccine for mistakes,” training is not responsible for most human error deviations. To ensure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss the elements necessary when implementing/improving a training program. We will discuss elements of the training programs like curricula, training management systems, training effectiveness, and other important elements of a compliant training program.
Areas Covered in the Session:
- GMP regulations on the training topic
- Agencies expectations of the training program
- Training general aspects
- Responsibilities of the training program
- Requirements for New employees
- Transferred Employees
- External Service Providers
- Training Events
- Skills Qualification Program (OJT)
- Training Assessment
- Retraining
- Training Outline/Contents
- GMP
- Technical Training
- On the Job
- Training Frequency and Topics
- Instructor’s Qualifications
- Training Curricula
- Training Documentation
- Review of Training System Effectiveness
- Deviations related to performance
Who Will Benefit:
- Training Managers and Coordinators
- Operations
- Manufacturing
- Plant Engineering
- QA/QC Staff
- Process Excellence/Improvement Professionals
- Industrial/Process Engineers
- Compliance Officers
- Regulatory/Legislative Affairs Professionals
- General/Corporate Counsel
- Executive Management
Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.
She is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.