Description:
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 to be Covered:
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 will Benefit:
Quality Managers
Quality Engineers
Production Teams
Research and Development Teams
Compliance Teams
Documentation Teams
GxP
Regulatory Affairs professionals
Consultants
Small business owners
