To be a compliant organization, we must meet different characteristics, which in turn broaden the scope of the GMP application and approach. We in our firm are committed to conforming to the ability to sustain performance over time and over changing business circumstances. Also, the approach for performance reliability does not circumscribe to training strategies exclusively as a means to improve performance but addresses other areas that impact behavior as well.

KEY: Flawless execution- Assure that employees have all the necessary tools to execute and perform achieving their optimal level of skill and quality, by providing support early in the process design, more than creating training programs after the fact.

Areas that affect execution:

• The inclusion of human factors in training design so the human interface is appropriate and that training programs can capture critical areas.
• Well-written work instructions that take into consideration mental processes to decode messages.
• Identification of critical tasks and steps to assure training program is designed highlighting the criticality of each one.
• Training designs that prepare operators for unexpected situations.
• Programs that consider elements like the level of attention, motivation, and situation awareness needed for the particular tasks.

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.
  • 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.          

Learning Objectives:-

• Learn essential 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.

Why Should You Attend?

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 make sure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss 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.

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