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Writing SOP’s and Work Instructions that Really Work

January 20 - 21, 2026 | US Eastern Time: 11 AM to 3 PM | Central Europe Time: 5 PM to 9 PM

$1200 
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Standard Operating Procedures and Work Instructions are often treated as paperwork to “get through”—but when written the right way, they become powerful tools that drive compliance, efficiency, and performance. This seminar is designed to help life science professionals stop writing documents nobody reads and start creating SOPs that actually work in practice. Over two intensive days, you’ll learn how to transform technical writing into a practical skill that improves operations and satisfies FDA and ISO expectations.


The course breaks down the essentials: understanding regulations, tailoring documents to how people learn and work, and building layouts that are easy to use under real-world pressures. Through hands-on sessions and exercises, you’ll practice collecting information, collaborating with subject matter experts, structuring documents, and presenting procedures in a way that is clear, concise, and error-proof. By focusing on the connection between regulatory compliance and human performance, this seminar ensures your SOPs don’t just meet audit requirements—they make your teams more effective.


This isn’t about writing more paperwork. It’s about changing how organizations think about documentation. You’ll leave with the confidence to create SOPs and Work Instructions that prevent mistakes, reduce training time, and withstand regulatory scrutiny. If your role touches compliance, training, quality, or operations, this is one seminar you cannot afford to miss.


You will gain:

  • Clear understanding of FDA and ISO documentation expectations
  • Practical strategies for user-focused SOP and Work Instruction design
  • Tools for working effectively with subject matter experts
  • Insights into human performance and how people process information
  • Best practices for structure, visuals, and language that improve usability
  • Technical writing skills tailored to life sciences documentation


Agenda:

DAY 1 (11 AM to 3 PM)


Lecture 1:

Where do SOPs and Work Instructions Fit? – An Overview

  • The relationship between regulatory documentation (SOPs and Work Instructions), training and regulatory compliance, operational excellence, and why it is important.
  • The purpose and function of SOPs and Work Instructions.
  • The Documentation and Operational Performance Model.
  • The relationship of corporate knowledge to value and human performance.
  • Includes reference to FDA 21 CFR Part 820 for QSR and ISO 9001:2015 for QMS.


The Rules of Technical Writing

  • Readability.
  • Understand the content.
  • Use signposts.
  • Don’t violate standards.
  • Technical terms.
  • Structuring and formatting your documentation – templates.
  • Harmonize your documentation.


Lecture 2:

Regulatory Compliance and SOPs and Work Instructions

  • Manage documentation.
  • Where and why procedures are required.
  • The need to be a successful writer in the life sciences.


The Technical Writing Process

  • Analyze the audience.
  • The reader profile.
  • The project team.
  • Executional considerations.
  • Planning the content – the outline.


Lecture 3:

Gathering Technical Information – Working with Subject Matter Experts

  • Relationship building.
  • Active listening.
  • Paraphrasing.
  • Questioning.
  • Avoiding Assumptions.
  • Remove communication barriers.
  • Challenge.
  • Compromise.
  • Setting expectations.
  • The data gathering process.


Utilizing Graphics

  • Types of graphics.
  • Typical photographs.
  • Digital photographs.
  • Drawings.
  • Typical schematics.
  • Flowcharts.
  • Tables and graphics.


DAY 2 (11 AM to 3 PM)


Lecture 4:

Ensuring Accuracy and Utility

  • Goals of the review.
  • Review the criteria.
  • What to look for.
  • The document review.


Technical Writing Basics

  • Use clear and concise language.
  • Avoid jargon.
  • Define the unfamiliar.
  • Brevity.
  • Simplicity.
  • Write clearly.
  • Make good word choices.
  • Be clear and concise.
  • Using active and passive voice.
  • Organize your content.
  • Separate action steps from information. 


Lecture 5:

What are Tasks

  • Grouping tasks.
  • Constructing action steps.
  • Using action verbs.


Grammar Mechanics

  • Grammar.
  • Numbers.
  • Abbreviations.
  • All-inclusive words.
  • Synonyms.
  • Vocabulary. 


Lecture 6:

Special Considerations

  • Non-native language considerations.
  • Controlled English.
  • Global English.
  • Focus on ISO 30401:2018 for knowledge management systems.


Technical and Process Descriptions

  • Technical processes.
  • Procedures and work instructions.


Course Director:

Charles H. Paul, President of C.H. Paul Consulting, has spent over 20 years shaping regulatory, training, and documentation programs for life science companies worldwide. A seasoned consultant, he has authored numerous white papers and built compliance solutions for both domestic and global organizations. With unmatched expertise in regulatory writing and Lean-based documentation, Charles is the ideal mentor to help you master SOPs that truly work.