11:00 AM - 03:00 PM

Module 1: Technical Writing Overview
- What is technical writing
- What role does technical writing play in the life sciences?
- Essential elements of technical report sections
- Learn strategies for organising, writing, editing, and proofing documents & correspondences
- Will teach you methods to evaluate your writing style and apply steps to express complex ideas more clearly and concisely.

Module 2: Technical Writing Basic rules and skills required for technical writers
- How to begin the process
- How to collect information and determine what information is required
- Formats, consistency and styles
- Non-native audience considerations
- Grammar, spelling, punctuation, numbers and symbols
- Simplify your writing
- Ensuring accuracy
- Understand your own writing patterns and know the answers to your questions about the English language
- How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing

Module 3: Knowing the Audience
- Analysing the audience
- Analysing the information – working with Subject Matter Experts
- Know how to review and revise documents
- How to address comments from reviewers
- How to negotiate with reviewers when disagreements arise between reviewers
- Learn to increase confidence in writing and revising documents
- Assessing and writing to the audience to produce effective written correspondence
- Effective techniques for extracting information from SMEs

11:00 AM - 03:00 PM

Module 4: Regulatory Requirements
- FDA expectations for quality of written text in submitted documents
- Common opportunities that are often overlooked or under-estimated by aspiring writers
- Technical writers in the life sciences – what do they write – types of medium
- Mandates for documentation set forth by regulators, such as the FDA, the International Organization for Standardization (ISO), and other governing bodies
- How to write effective summaries and respond to FDA requests for information

Module 5: Final Document
- How to incorporate comments into the final document
- How to obtain comments in order to address timelines
- Final approval of the document
- Critical aspect of writing technical documents for the life sciences will be addressed with the goal of helping you become a better technical writer.
- How documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final study report
- Reports Editing and Completion

Module 6: Summary
- Q/A Session with the Course Instructor
- Case study and Many Exercises
- Discuss your current challenges