Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)
This medical writing course’s notes and interactive exercises address how to write effective correspondence and reports in support of the company's activities. You will learn how to organize and deliver information for the intended audience, as well as how to write clear and readable documents, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues.
Who Should Attend
Scientists, engineers, and technicians in research and development will find this medical writing course valuable, as will quality assurance (QA), information technology (IT), manufacturing, and other operations professionals. This technical writing training course is also useful for administrative staff that must prepare documentation in support of R&D and operations activities. Additionally, the course is helpful for anyone who wants an in-depth and comprehensive overview of the structure of the language and writing within the broad range of reporting that the industry requires.
Course Agenda
First Day
Regulations and Industry Standards
- Setting the foundation
- What is technical writing and what makes it good?
- Regulatory requirements and good business practices
- The purpose of each document
- How documents work together
- Maintaining the product "thread" from document to document
Addressing the Audience
- Writing directly to the reader
- Focusing on the message
- Being technically appropriate
- Using terminology the reader understands
- Using acronyms and defining terms
Organizing Information
- Using suitable patterns to deliver effective messages
- Composing letter, fax, and e-mail messages
- Applying industry standards for effective reports
- Using document templates
- The writing process
- Writing Effective Headings
- Using Tables and Figures
- Completing the document
- Metrics: managing the process from start to finish
- Formal Review
Writing Effective Passages
- Understanding the function of specific passages
- To describe
- To compare and contrast
- To define
- To show cause and effect
- To show sequence
- To summarize
- Writing clear topic sentences
- Giving enough information to convince
- Referencing other writers
Second Day
Controlling the Language
- Conventions of the English language
- Writing grammatically sound sentences
- Combining and subordinating information
- Making every word count
- Using transitions
Using the Right Tense and Voice
- The writer's voice
- Remaining objective
- Using the subjunctive, imperative, and emphatic voice
- Using the active voice
- Paring the passive
Punctuating Effectively
- Using punctuation to clarify messages and improve readability
- Bullets, numbers, white space
- Using symbols and abbreviations
Writing Workshop
- The writing process
- Describing a mechanism
- Revising and fine tuning
Third Day
Writing Workshop
- Achieving clarity and readability
- Assessing your own writing
- Making every word count
- Participants' writing concerns
The Writing Environment in Industry
- Writing in the industry over time
- Projections for documentation practices
Learning Objectives
Upon completion of this course, you 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 reporting process supports products in research, development, and the marketplace
- Understand how documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final study report
- Know how to produce effective written correspondence
- Understand how to assess and write to the audience
- Know how to organize and deliver information based on the message
- Understand how to structure reports
- Understand the innate structures of English grammar
- Know how to create grammatically sound passages
- Understand 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
- Have increased confidence in writing and revising documents
Frequently Asked Questions
When writing a GLP study report, can we copy the study plan from the protocol and insert it into the document?
Many companies "cut and paste" from the protocol, but without adjustment in tense, they risk creating confusing documents. The protocol reflects what a company plans to do; the study report tells what happened during the study and what the outcome is. Thus, it's important that the study report describes the plan in the past tense, not the future, reflecting what has already occurred.
We believe we are always objective in our CAPA summaries when stating what happened, but FDA cited our documentation for being unclear in who did what. How can we be more precise?
There is a conception that scientific writing must be in the passive voice to be objective, but in certain types of documentation, such as CAPA summaries, the passive voice can permit the omission of critical information. Consider the following:
A package of X was returned to the retail point of purchase. Via telephone, the package was reported to contain loose white powder with the tablets, and the package was sent back to manufacturing the following day.
Using the active construction necessitates an agent of action, and there's no doubt as to who did what.
A pharmacist reported, via telephone, that a customer had returned a package of X because of loose white powder with the tablets in the package. The call center requested return of the package, and the pharmacist shipped it the next day.
So much of what we write involves comparisons between test groups, but our comparisons don't seem as clear as they should be. How can we improve?
Making comparisons and assessing variations and differences are integral to the development of most therapeutic products. Where writers frequently fall short is failing to compare the right things. Consider this sentence: Residue in the liver of the hamster was greater than in the rat. A sentence like this says that the comparison was between residue in liver of the hamster and residue in the entire rat. An easy fix is to recast such a sentence as follows: Liver residue was greater in the hamster than in the rat. Here's another example of the same sort of illogic: The results of this study are similar to the last study. Careful writers compare results to results, as in the following sentence: The results of this study are similar to those of the last study.
