Technical Writing for the Pharmaceutical, Medical Device & Biotech Industries

Scientists, engineers, and technicians in research and development will find this course valuable, as will quality assurance (QA), information technology (IT), manufacturing, and other operations professionals. This 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.

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

Course Description

Course 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. You will learn 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. Participants receive a copy of Write It Down: Guidance for Preparing Effective and Compliant Documentation, 2nd Edition (Francis and Taylor).

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COURSE AGENDA

DAY ONE

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 correspondence
• 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

DAY TWO

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

DAY THREE

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