Writing World Class Compliance documentation – SOPs & Work Instructions

Duration 60 Mins
Level Basic & Intermediate
Webinar ID IQW19E0527

  • 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
  • Writing effective compliance documentation

Overview of the webinar

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.  

This webinar will present the methodology to make Standard Operating Procedures and Work Instructions a valuable component of the operational strategies of any regulated organization.

Who should attend?

Quality, production, compliance, engineering, R & D, management – essentially everyone in the organization that is tasked with creating regulatory documentation.

Why should you attend?

Writing effective compliance documentation 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.

These documents are critical to regulatory compliance but they are also critical to effective business operations. Because the process of effectively developing these documents is not intuitive, it is imperative that everyone tasked with creating these documents have basic foundational knowledge of how to create effective documents with a minimum of effort.

Faculty - Mr.Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, 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.

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