Writing Effective Regulatory, Medical and Technical Documents

Zeinab Schwen

Course description

The success of a company’s drug product or medical device regulatory submission is heavily dependent on the quality of its documentation submitted to regulatory authorities. Therefore, crafting precise, concise, well-referenced, and unambiguous technical documents is vital for business success. To produce such high-quality documents, effective writing skills must be continually honed.

In this accredited course, you will acquire techniques to assess your writing style and implement strategies for presenting complex ideas in a clear and concise manner. Through a blend of lectures and class exercises, you will learn methods for structuring, writing, revising, and proofreading documents and correspondences. Additionally, the course will cover critical components of technical report sections and provide guidance on writing effective summaries and responding to FDA requests for information.

Upon completion of this course, you will be able to:

• Describe your role as a writer and your ethical responsibilities
• List the regulations controlling quality documentation
• Evaluate your writing patterns and style
• Assess your audience for each document to improve readability
• Identify basic strategies for crafting effective messages and enhancing comprehension
• Write more concise sentences and paragraphs
• Improve your editing skills
• Apply learnings to improve document quality