Creating and Maintaining an Effective and Efficient Technical Training Program

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 180 Min Live Webinar

"Hear By Dr. Ginette Collazo — a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors"

GMP regulations on the training topic.


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

Key Learning Objectives of your Topic:

•    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. 

Areas Covered

•     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.

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

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

DR. Ginette M. Collazo

DR. Ginette M. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, 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.

Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.

Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.

Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.

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