Course Description
Fundamentals of Technical Writing for the Life Sciences Industry is designed for those in the Life Sciences industry who need to write about their work or submit their work to a regulatory body. Training includes an overview of Technical Writing and Regulatory Agencies and Regulations, as well as technical instruction on writing for the regulatory audience: sentences and paragraphs, word use, punctuation, readability, and the writing and review process.

Who Should Attend
This class is designed for writers in Regulatory, Quality, Clinical, CMC, or other technical functions.

Learning Objectives
Through training, participants will:

• Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• Know how the writing and reporting process supports products in research, development, and the marketplace
• Understand how documents work in tandem from initial correspondence about a project to approved protocols, amendments, and final study reports
• Know how to produce effective written correspondence
• Understand how to assess and write to your audience
• Know how to organize and deliver information based on the message required
• Understand how to structure reports
• Understand the innate structures of English grammar and create grammatically sound writing
• Learn how the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
• Have a working knowledge of punctuation marks and their role in making documents readable
• Know how to review and revise documents
• Understand your own writing patterns and know the answers to your questions about the English language
• Increase your confidence in writing and revising technical documents

Course Outline

Day One

• Importance of Technical Writing
• Regulatory Agencies and Regulations
• What Documents are Covered?
• Who is your Audience?
• Passive vs Active Voice

Day Two

• Writing Sentences & Paragraphs
• Word Use
• Punctuation
• Ensuring Readability
• Writing and Review Process

Course Format
16 hours
Combination slide presentation and interactive small-group exercises
Available at QSG’s training facilities and on-site at your organization