Building GMP Excellence: A Guide to Implementing Compliant Training Programs

Human error is often blamed on weak training, yet training is not responsible for most human error deviations. This 90-minute GMP training program webinar explains how to build a program that is effective and can be ruled out as a root cause.

You'll review what GMP regulations and agencies expect from a training program and the elements needed when implementing or improving one, including curricula, training management systems and training effectiveness.

The session covers requirements for new and transferred employees and external service providers, skills qualification through on-the-job training, assessment, retraining, instructor qualifications, documentation and reviewing how well the training system works.

• Describe the key elements of a training program in a regulated environment
• List key performance indicators for training
• Develop a GMP training program
• Measure training effectiveness
• Determine when training is responsible for human error deviations

• GMP regulations on training
• Agency expectations of the training program
• General aspects of training
• Responsibilities within the training program
• Requirements for new employees, transferred employees and external service providers
• Training events
• Skills qualification program (OJT)
• Training assessment and retraining
• Training outline and contents: GMP, technical and on-the-job training
• Training frequency and topics
• Instructor qualifications
• Training curricula
• Training documentation
• Reviewing training system effectiveness
• Deviations related to performance

When a deviation is traced to human error, regulators expect you to show whether training played a part. A well-designed, documented training program lets you answer that question with confidence.

This session suits training managers and coordinators, operations, manufacturing and plant engineering staff, QA/QC, process improvement professionals, industrial engineers, compliance and regulatory affairs professionals, legal counsel and executive management.

• 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

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.Ginette Collazo, Ph. D. 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.