How to create an effective and GMP compliant Training Program and reduce Training related human errors
Training programs have evolved. 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 aspects of the training programs like curricula, training management systems, training effectiveness, and other essential elements of a compliant training program. Areas Covered GMP regulations on the training topicAgencies' expectations of the training programTraining general aspectsResponsibilities of the training programRequirements for New Employees Transferred Employees External Service Providers Training Events Skills Qualification Program (OJT) Training Assessment Retraining Training Outline/Contents o GMP o Technical Training o On the Job Training Frequency and Topics Instructor’s Qualifications Training Curricula Training Documentation Review of Training System EffectivenessDeviations related to performance AI IntegrationLearning Objectives Learn critical elements of the training program in a regulated environmentList Key Performance Indicators related to trainingLearn to develop a training programLearn how to measure training effectivenessLearn when training is responsible for human error deviations Use of AIWho Should AttendTraining managers and coordinatorsOperationsManufacturingPlant engineeringQA/QC staffProcess excellence/improvement professionalsIndustrial/process engineersCompliance officersRegulatory/legislative affairs professionalsGeneral/corporate counselExecutive management
Training programs have evolved. 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 aspects of the training programs like curricula, training management systems, training effectiveness, and other essential elements of a compliant training program.
Areas Covered
- 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
o GMP
o Technical Training
o On the Job - Training Frequency and Topics
- Instructor’s Qualifications
- Training Curricula
- Training Documentation
- Review of Training System Effectiveness
- Deviations related to performance
- AI Integration
Learning Objectives
- Learn critical elements of the training program in a regulated environment
- List Key Performance Indicators related to training
- Learn to develop a training program
- Learn how to measure training effectiveness
- Learn when training is responsible for human error deviations
- Use of AI
Who Should Attend
- 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
