Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.
This seminar will also 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. And how together, effective documentation and training can significantly improve your operations.
Areas Covered:
Session 1:
Achieving Excellence through Training & Documentation
- The relationship between human behavior and organizational performance
- How training, documentation, and management action impact operational excellence – elements of compliance excellence
- The cost of human capital – what it costs and what it can yield
- Making it all real – let’s look at a case study
- Implementing the model in your organization
Session 2:
Regulatory Documentation – The Foundation
- The true purpose and function of regulatory documentation
- What is the value add?
- The pitfalls associated with writing regulated documentation
- The documentation hierarchy
- Documentation formats
- Gathering the technical information you need
- Using Subject Matter Experts
- Documentation writing tips
- Managing technical document reviews
Session 3:
Training & Development – the Implementation Method
- 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
Session 4:
Putting it all Together
- Building an effective training function
- Training trainers
- Executing effective training
- Testing to assure competence
Who Should Attend:
Members of:
- American Society for Quality
- American Pharmaceutical Manufacturers of America
- Generic Drug Manufacturers Association
- National Pharmaceutical Association
- International Society for Pharmaceutical Engineering
- Medical Device Manufacturers Association
- European Medical Device Technology
- Gulf Coast Medical Device Manufacturers
- American Society for Training and Development (ASTD)
- Training and Development Departments
- Operations Departments
- Documentation Departments
- Manufacturing Departments
- Quality Departments
- Production Departments
- Regulatory Departments
- Compliance Departments
- Technical Services
- Human Resources Departments
- Research and Development Departments
- GxP Professionals
- Consultants
- Small business owners