Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)

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 knowing how to write those documents to properly meet those needs.

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 webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Areas Covered in the Session :

• SOPs and their relation to the regulations
• 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

Who Should Attend:

• Quality Managers
• Quality Engineers
• Production Teams
• Research and Development Teams
• Compliance Teams
• Documentation Teams
• GxP
• Regulatory Affairs professionals
• Consultants
• Small business owners

Course Director: CHARLES PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.