This message is sent to you by FDA Newswatch

Writing Effective Standard Operating Procedures and Work Instructions 

Thursday, 24 October 2019 10:00 AM PDT, 01:00 PM EDT

Training Duration = 60 min                  Sponsored by Online Compliance Panel

Click Here to register $229.00

Click Here to register and receive CD recording $329.00

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

Objectives of the Presentation:

  • Discuss the regulatory requirements as they relate to SOPs and Work Instructions within the US and the EU
  • List and describe the benefits that effective regulatory documentation can provide the organization - specify the value add
  • Explain how regulatory documentation can serve as a significant component of any technical training program
  • Discuss why it is important to have a documentation hierarchy
  • Explain how best to determine/identify your regulatory needs and gaps in the regulatory portfolio
  • Explain the importance of having user-friendly documentation templates as the basis of your documentation process
  • Explain how to best gather technical information for regulatory documentation - efficient, effective, and technically accurate
  • Explain how to best work with subject matter experts to develop regulatory documentation
  • Explain writing styles, formats, and content requirements that must be addressed to prepare effective documentation
  • Explain the documentation development process to include how reviews and revisions are best addressed

Why Should You Attend:

Writing effective Standard Operating Procedures (SOPs) 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.

Areas Covered:

  • 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

Instructor Profile:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, 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. The firm works globally completing projects throughout the EU, UK, South America, and Asia.