Fundamentals of Technical Writing for the Life Sciences Industry

Course Summary

This course provides 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.

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Event Details

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

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

Prerequisites

None

Instructors

FAQ

What transferable skills will I gain from this workshop?

This course will help you develop clear and concise technical writing, regulatory documentation, compliance reporting, standard operating procedures (SOPs), and data presentation skills, essential for professionals in the pharmaceutical, biotechnology, and medical device industries.

What other Life Sciences and Regulatory Compliance courses does QSG offer?

QSG offers a variety of technical writing, regulatory compliance, and quality management training programs, including FDA Requirements Training, ISO 13485, and CAPA (Corrective and Preventive Action).

What if I want to customize this course for my company?

We offer customized Technical Writing training tailored to your organization’s specific regulatory and documentation needs. Contact us at info@qualitysupportgroup.com to discuss personalized training solutions.

Will I receive a certificate after completing this course?

Yes! Participants will receive a Certificate of Completion, demonstrating their proficiency in technical writing for the life sciences industry.

How can I register for this course?

You can register online by selecting your preferred course dates and completing the enrollment process.

How can I become a QSG member and receive discounted training?

QSG members receive exclusive discounts on training programs.

General FAQ 1

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General FAQ 2

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

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