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 as good as its effectiveness. To make sure training programs are effective, we should be able to measure and demonstrate mastery of performance before releasing employees for independent work. We will discuss elements necessary when creating and developing measurement instruments (tests). We will also discuss elements of the training programs like objectives, training content, training effectiveness, and other essential elements of a compliant training program. 

Webinar Takeaway

  • GMP regulations on the training topic.
  • Agencies’ expectations of the training program.
  • Training general aspects.
  • Responsibilities of the training program.
  • Training Events.
  • Skills Qualification Program (OJT).          
  • Training Assessments and construction.
  • Retraining.        
  • Training Outline/Contents.
  • GMP
  • Technical Training
  • On the Job        
  • Training Frequency and Topics. 
  • Instructor’s Qualifications.         
  • Training Documentation.           
  • Review of Training System Effectiveness.
  •  Deviations related to performance.     

Learning Objectives

  • Learn critical elements of the training program in a regulated environment.
  • List Key Performance Indicators related to Training.
  • Learn to develop a training assessment.
  • Learn how to measure training effectiveness.
  • Learn when Training is responsible for human error deviations

Who Will Benefit

  • 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
FDA Faculty Ginette Collazo

Faculty Ginette Collazo

CEO Human Error Solutions

Miami, Florida, United States

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.

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