This 3-hour virtual seminar webinar will explore in-depth the topic of training in regulated environments, its importance, and its relationship to compliance documentation and most importantly to bringing real measurable benefit to the organization.
Training is one of the most underrated and least respected of all the disciplines found within modern manufacturing particularly 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. One of the major areas to be explored will be training process and how you can design training delivery to be both cost effective as well as efficient, and impactful. We will also look at the role that human behavior plays in how people learn, how people perform, and how people perceive and interact with their environment.
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, competence impacts performance and competence impacts safety. We will also look at and examine how compliance documents should be crafted to achieve maximum benefit across a broad spectrum of the enterprise. We will complete this virtual seminar by discussing several case studies that demonstrate "Best Pratice" with some of the largest life sciences companies.
Why Should You Attend?
The application of training and development in the life sciences is a unique application of the function as opposed to non-regulated industries. There is a significant relationship between regulatory compliance as a whole, compliance documentation, and training and development that is critical it be understood and exploited for maximum efficiency and impact to the organization. There is an increasing trend for regulatory agencies to view compliance documentation and training with increased scrutiny. This scrutiny and the benifits of training and development to the bottom-line can significantly contribute to improvements, cost reductions, cost improvements, and cost avoidances directly as they impact the functions comprising the enterprise. Training professionals must be aware of how these key pieces fit together and can be applied for maximum benefit. Training and development should never train to request but train to need. Attending this webinar will provide training professionals with unique insight into how training is best integrated in the the enterprise's information system and applied in unique regulated environments for maximum benefit.
- Global regulatory requirements for compliance documentation and training
- The relationship between compliance documentation and training
- Read and understand versus demonstrated competence
- Human performance - how/why people perform the way they do - how training is impacted by human performance
- Basic human needs
- Elements of a compliant documentation and training system
- Implementing training in the Life Sciences
- Compliance documentation and training as the basis for world-class operational control and performance improvement
- Case study review
C. H. Paul Consulting, Inc.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, training, and technical documentation consulting firm.
Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence.
He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
This 180-minute online course is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
- Directors of Training
- Training associates
- Training developers
- Training managers and directors
- Compliance managers
- Compliance directors
- Instructional Designers