Leverage Regulatory Documentation – Write SOPs that Actually Work and Have Value
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.
Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to know how to write those documents to properly meet those needs.
- 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
Course Level - Basic/Intermediate
Who Should Attend
This webinar will benefit everyone in the life sciences particularly those that work within the pharmaceutical and medical device settings, engineering, quality, and regulatory functions or services to include, machine operators and mechanics, quality assurance, technical services, laboratory, regulatory, engineers, documentation development and management with titles such as associates, technicians, scientists, supervisors, managers, and directors – essentially everyone in the organization that is tasked with creating regulatory documentation.
Why Should You Attend
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.