Writing Effective Standard Operating Procedures and Work Instructions
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance problems.
Standard Operating Procedures and work instructions – 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 approach and philosophy here are new to the industry and focus on achieving maximum benefit of compliance documentation across many applications to achieve both operational efficiencies and compliance excellence.
This webinar will discuss how to transform your regulatory documentation process a profit center, an operational force multiplier in how you run your business, and an effective central focus of your technical training function.
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.
- Define the true purpose and function of regulatory documentation
- Determine the value-add that regulatory documentation can bring to your organization
- Identify the pitfalls associated with writing regulated documentation
- Explain the purpose and function of a documentation hierarchy
- Explain how a document is created
- Identify and explain the best types of formats that can be used to develop standard operating procedures and work instructions
- Explain the best techniques for gathering the technical information you need to develop your documents
- Explain how to most effectively work with Subject Matter Experts
- Explain how to streamline and managing technical document reviews
Who Should Attend
Anyone tasked with the development of regulatory documentation in any regulated industry - the Life Sciences (medical devices, pharmaceuticals, biologics, etc), foods, cosmetics, beverages, nutraceuticals, etc.