Creating and Maintaining an Effective GMP compliant Technical Training Program 2023

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though training is considered the “vaccine for mistakes” training is not responsible for most human error deviations. In order 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. 

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 on 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.

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. 

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 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

Course Director: Dr. Ginette Collazo

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. 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.