Regulatory Writing: Plain Language [5.0 RAC] (5 CE points)
In the high-stakes world of regulatory writing, it is essential to approach your work with objectivity and to prioritize clarity and precision. The course will provide insights into your writing strengths and weaknesses, helping you improve with focused intent. This course emphasizes the importance of objectivity, clarity, and precision, providing valuable insights into individual writing strengths and areas for improvement.
Throughout the course, participants will explore a variety of topics, including fit-for-purpose writing, organization, and persuasiveness. Practical exercises and real-world examples will guide learners in applying these concepts to their writing. Special attention will be given to email communication and editing techniques to ensure that written correspondence is professional and impactful.
By the end of this course, you will be equipped with the skills to make your writing clear, effective, and impactful, positioning you as knowledgeable, credible, and articulate in your field.
At a Glance
- Target Audience: This course is designed for regulatory affairs professionals who write, review, or manage regulatory documents and communications. It is also valuable for quality, clinical, and cross-functional team members who contribute to regulatory content and want to improve clarity using plain-language techniques.
- Learning Level: Basic
- Total Length of Course: 5 Hours
- RAC Points: 5
Learning Objectives
Upon completion of this course, participants should be able to:- To understand the principles of plain language
- To practice creating clearer, more concise, more effective writing
- To provide strategies for planning, writing, and reviewing
Lesson Titles
- Lesson 1: Introduction
- Lesson 2: Fit-for-Purpose Writing
- Lesson 3: Clarity in Our Writing
- Lesson 4: Concise Writing
- Lesson 5: Organizing Our Writing
- Lesson 6: Persuasive Writing
- Lesson 7: Email Writing
- Lesson 8: Editing Our Work
Enrollment Period: 12 months
Author Biography: Lesley Worthington
Lesley Worthington is a Communication and Leadership Coach and former Quality Assurance and Regulatory Affairs professional with more than two decades of experience in the medical device industry. She now works with quality and regulatory leaders to strengthen their communication skills — including writing, influence, executive presence, and cross-functional leadership — so their expertise is understood, trusted, and acted upon. Her background in psychology, law, and executive coaching informs her practical, structured approach to helping technical professionals communicate with clarity and authority.
