How to Create an Effective and GMP-compliant Training Program and Reduce Training-related Human Errors

The session covers GMP regulations, agency expectations, training responsibilities, new employee requirements, external service providers, skills qualification programs, assessment, retraining, technical training, job frequency, instructor qualifications, curriculum, documentation, performance review, and AI integration.
  • Tuesday
  • June
  • 03
  • 2025
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
IMG Ginette Collazo
Webinar Id: 61039
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

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 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
  • AI Integration

Who Will Benefit:

  • Training Managers and Coordinators
  • Operations
  • Manufacturing
  • Plant Engineering
  • QA/QC Staff
  • Process Excellence/Improvement Professionals
  • Industrial/Process Engineers
  • ComplianceOfficers
  • Regulatory/Legislative Affairs Professionals
  • General/Corporate Counsel
  • Executive Management

Speaker Profile

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.