Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.
Day 1 of this seminar will concentrate on providing foundational knowledge concerning training and development within the Life Sciences. Four 90 minute sessions will be presented on this first day that will guide the participant from a discussion of the role and function of the technical training function to the actual creation of the training organization. Important to this first day, are discussions of performance-based training, the fundamentals of training (jobs, duties, tasks, and steps to include performance objectives) and how human performance and training are inextricably linked. Knowing about human performance and how to apply human performance principles are crucial to designing, developing, and managing an effective technical training function.
Day 2 will continue to build the foundation by first addressing how a documentation and training analysis is conducted to identify gaps that need to be filled and the training curriculum designed. The critical issue of training materials and how Standard Operating Procedures and Work Instructions can partially fill that role is covered in some depth. Subject Matter Experts are crucial to effective training development in any technical training setting. Session three of day two will discuss how to best work with SME's to achieve the best results and also how to select and work with outside consultants if necessary.
The seminar will close with a discussion of three case studies that will showcase and make real the many concepts presented.
Throughout the seminar, activities will be presented that will reinforce all learned concepts. Every opportunity will be provided for a sharing of ideas and a discussion of the concepts presented.
Printed handouts and pamphlets will be provided to document seminar content and to provide participants with take-away material.
Why Should You Attend?
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. Not knowing or understanding these approaches or applications of the tenants of the profession will place any individual at a great disadvantage when attempting to solve the sometimes overwhelming problems that must be faced when implementing "world-class" training and meeting the regulatory needs of the organization.
Many training managers and training coordinators have secured their management positions because of their expertise and success in fields of study and in aspects of the business other than Training & Development such as science and engineering. Training and Development is a professional field of study as any other. Other training managers may have Training & Development experience but in other aspects of the field and not true technical training. Still others may be technical Training & Development professionals but would benefit from a fresh look at how others are tackling the difficult problems that technical training pose in Life Science applications.
This is precisely why this two-day seminar was created, to "jump start" talented and technically competent training professionals that may need more focused instruction and direction in the area of technical training in the Life Sciences. It was also developed to provide guidance to all training professionals at all skill levels in how to truly build and sustain a training organization in today's difficult corporate environment, and how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are readily available.
One of the most important benefits of this seminar is the achievement of an understanding of how Training & Development and compliance can be integrated to leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.
Day 1 Schedule
Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance
- Purpose and function of the Training and Development organization in the Life Sciences.
- What is training's value - is it a cost center or a profit center?
- What is the relationship between Training and Regulatory Compliance and why is it important?
- What would a typical training organization look like?
- Best practices in Training & Development
Training and Development Basics
- Training adults, the challenge facing us all
- What is performance-based training - the process explained?
- The building blocks of technical training - Job, Duties, Tasks and Steps
- Learning objectives - what are they and why are they important?
- What is a curriculum and why is it important?
- Selecting tasks for training (What is a task performance and learning analysis?)
- Selecting the appropriate training media and method
The Building Blocks of Human Performance
- Why do we behave the way we do?
- The 6-cell performance engineering model
- The difference between behavior and accomplishment
- How does Performance-Based Training impact human behavior?
Building a Training and Development Organization - Leverage what you have and Negotiate for What You Don't
- The Training & Development Strategic Plan
- Building your Training & Development organization
- Training infrastructure - what do you need and what is really nice to have?
- Staffing your training organization - training developers, trainers, technical writers, and Subject Matter Experts
Day 2 Schedule
Perform a Documentation and Training Analysis - Discover the Gaps
- What is a Documentation and Training Analysis and why is it important?
- What are the steps of the analysis process (Regulatory Analysis, Process Analysis, Job Analysis, and Equipment Analysis)?
- The Analysis Tool - How is it structured and how is it used?
- Making training decisions based upon your findings
Training Materials - SOPs and Work Instructions as Training Materials - It's not as easy as you Think! Leverage the Opportunity!
- Basic attributes and uses of compliance documentation.
- The documentation hierarchy and the uses of each type of document.
- How compliance documents aid in job performance and operational effectiveness.
- SOPs and Work Instructions as Job Aids
- SOP and Work Instruction templates why they are important.
- Explain how effective SOPs and Work Instructions are developed.
Working with Subject Matter Experts and Outside Consultants
- Working with consultants - your responsibilities - assigning resources
- What is a Subject Matter Expert?
- How do you work with SMEs to achieve your best data gathering results
- The role of photography in data gathering
- When to use outside consulting support.
- Consultants versus temporary employees.
- Selecting the best consulting company.
Case Study Review and Discussion - This Approaches Works!
- Case Study #1 - NoKem
- Case Study #2 - Consumer Products - Disposable Diapers
- Case Study #3 - Global Harmonization
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.
DoubleTree by Hilton Philidelphia Airport
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Take Garage Access Rd, Exit 13 and Island Ave to Executive Ave,
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DoubleTree by Hilton Philadelphia Airport,
4509 Island Ave, Philadelphia, PA 19153, USA.