Live Webinar Technical Training in the Life Sciences
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar
"Hear By Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"
Training and Development has its own body of knowledge and a wide range of techniques and approaches designed to meet unique and complex training challenges
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.
Why should you attend :
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.
At the completion of this training participants will be able to:
• Define training in the context of compliance and regulated manufacturing
• 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
• Training beyond GMPs
• 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
Who will Benefit
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. 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
Industries who can attend
This 60-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.