Standard Operating Procedures and work instructions – the compliance documentation required by regulation – are 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 standard operating procedures and work instructions 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 address the new thinking as to how documentation hierarchies should be organized to reflect a global focus on how your documentation should be structured.
This webinar will also 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 (and wrongfully) unimportant work task.
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.
This webinar has a very broad base from which to solicit participants. Virtually any regulated industry as previously defined and virtually any job classification level – associates through managers and in virtually any organizational function – operations, facilities, logistics, purchasing, laboratory, research and development, engineering, maintenance, etc.
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.View all trainings by this speaker