Developing Training in Regulated Environments

Overview

Training is the process by which individuals acquire skill and knowledge. There are a variety of approaches and techniques that should be applied to specific situations to achieve maximum effectiveness. Uninitiated training personnel often apply training techniques that are totally inappropriate for the situations for which they are utilized resulting in very ineffective training. Read and Understand is a technique that is and has been extremely abused in the training field within regulated industries for many years because it is cheap and requires the minimum expenditure of the organization’s resources. The problem with this approach is that it is totally inappropriate for the majority of situations in which it is applied. From a regulatory standpoint this is extremely important to know because ineffective training within regulated industries equals a potential for compliance deficiencies. In addition, there is a significant relationship between compliance documentation and training that has not escaped regulatory scrutiny. When regulators look at documentation they also look at training in terms of the individuals to which the documentation applies and vice versa.     

This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. Training is one of the most underrated and least respected of all the disciplines found within modern manufacturing within regulated industries – foods, cosmetics, beverages, medical devices, pharmaceuticals, biologics, etc. Yet, training is equally as important as any compliance discipline. The major problem today is how training is applied, how training is administered, and how training is managed within the modern regulated industry. We will look at Best-in-Class applications of training and how training can significantly contribute to not only world-class compliance but improved operational performance, improved quality, and improved employee/associate safety.

Objectives

At the completion of this webinar, participants will be able to:

• Define training’s impact upon human performance
• Explain the types of training applications that are appropriate in given circumstances
• Discuss how a training needs analysis is conducted as specified by regulation
• Define the training development process
• Explain the relationship between technical training and compliance documentation
• Discuss the training pitfalls and misapplications of training and their impact upon regulatory compliance
• Discuss the dangers in relying upon “Read and Understand”
• Explain how training should be managed in the modern regulated industry

Why Should You Attend

There is an increasing trend for regulatory agencies to view compliance documentation and training with increased scrutiny. Documentation and training that is improperly developed, implemented, and/or recorded presents a significant regulatory risk for manufacturers. In addition to meeting regulatory requirements, documentation and training, that is properly developed, also can serve as the basis for a well-controlled operation and a highly-competent workforce.   Competence impacts compliance.

Agenda

Day 1:

• Discussion of the role of training in regulated environments – what does world-class training look like?
• Types of training – what is their role – where does it fit into the work setting?
• The relationship between compliance documentation and technical training.
• The training process steps – what does it take to develop training? The training needs and gap analysis – what is it and how is it conducted?
• What is a Task analysis and why is it important?
• Exercise: Performing a basic task analysis

Day 2:

• Moving from the task analysis to actual training?
• Type of technical training
• The dangers of “Rad and Understand”
• How are training effects measured?
• Training pitfalls and misapplications of training and their impact upon regulatory compliance
• Training peer trainers – a hidden asset.
• Exercise: Specifying technical training

Who Will Benefit

Anyone having responsibility for training and compliance documentation in regulated environments – developers and managers.

• Training associates
• Training developers
• Training managers and directors
• Compliance managers
• Compliance directors