Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Ginette Collazo

We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Why should you Attend: 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.

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
– 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

Learning Objectives:
– Learn key elements of the training program in 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

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

Ginette Collazo , PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.