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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.

Webinar Oct 30 2025, Thursday 01:00 PM EDT 90 Minutes Intermediate Level Code: GRC0000103
Speaker
By GINETTE COLLAZO In All FDA Regulated Industry
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Share:

  • 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

  • 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

  • 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
GINETTE COLLAZO
20 Years
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with over 20 years of experience specializing in Engineering Psychology and Human Reliability. She has held positions leading Training and Human Reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. In 2009, Dr. Collazo established Human Error Solutions (HES), a training and consulting firm, and she has positioned herself as one of the few Human Error Reduction Experts worldwide. 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 tested globally in different industries. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. As a GMP expert, she has also been a Keynote Speaker at significant events worldwide. Ginette Collazo, Ph. D., is the author of several books, “Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.” In 2023, Human Error Solutions was named a top-ten industrial service provider by Manufacturing Outlook magazine and featured on ABC, Fox, NBC, and CBS news. She hosts The Power of Why Podcast—a show about human behavior in the workplace and critical thinking.

  • 90 Mins | Oct 30, Thu , 01:00 PM EDT

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