Hear By Dr. Ginette Collazo - a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors
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
- 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
- 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
Dr Ginette M. Collazo,
Owner - Industrial/Organizational Psychologist ,
Ginette M. Collazo, Inc.
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.
Her work experience is from Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, holds specialized studies in Human Reliability, and has authored various publications on this topic. Her most recent publication is "Error Humano: C4c06 Modelo de Determinación de Raiz Causa", a book that describes success factors that reduce human errors. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn’t when trying to change a culture from an error tolerant environment to an error free learning organization.
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.
Who will Benefit:
- Training managers and coordinators
- 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
- Pharmaceutical Industry
- Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel