2-Day Virtual Seminar

2-Day Virtual Seminar on Technical Writing in the Life Sciences - Writing Regulatory Documentation for Consistency, Clarity, Accuracy, and Utility

Charles H. Paul Instructor:
Charles H. Paul
October 8 & 9, 2024
08:00 AM PDT | 11:00 AM EDT
2 Days
Webinar ID: 502268

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Price Details
Live Webinar
$995 One Attendee
$1195 Corporate Live
Recorded Webinar
$1045 One Attendee
$1395 Corporate Recorded
Combo Offers
Live + Recorded
$1632 $2040 Live + Recorded
Corporate (Live + Recorded)
$2072 $2590 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.

An important aspect of this training is the focus on specific document types that may be Required to be completed within the life sciences to include investigations, submissions, procedure, etc.

Gathering the information to be included in the technical document requires collaboration between the writer and the various subject matter experts that possess the knowledge to be harvested. How that information is gathered can be an effective efficient process or an ineffective time-consuming endeavor all dependent upon the techniques employed to execute the activity.

We will address the most effective techniques for extracting information from SMEs as well as those techniques that work best when observing procedures and activities to be documented. We will end this webinar with the mechanics of technical writing ranging from planning and organizing the content through grammar, spelling and punctuation ending with writing simplification.

Why You Should Attend
Even with the advent of technology, we still communicate with the written word. Technical writing is about conveying information quickly, accurately, clearly, and succinctly. How we communicate, how we are understood, and how the message is received directly depends upon our skills as technical writers.

In the life sciences, this skill is exceedingly important. In the life sciences, the stakes are high in terms of the writing's ability to enable 100% accurate understanding of the content and where applicable, performance of the task or procedure documented. In the life sciences, that could mean the difference between life or death, safety or injury, loss or recovery, contamination or purity, success or failure.

Unfortunately, technical writing is not a skill that is given much emphasis in college curriculums if any. Technical writing is a skill life sciences workers are assumed to have and are expected to demonstrate at a level of skill usually beyond the capability of most. Unfortunately, most readers of technical writing are in the "same boat." They "don't know a good one when they see one." At the end of the day, in most cases, you have mediocre writing at best that may or may not convey the message intended.

This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents for the life sciences will be addressed with the goal of helping you become a better technical writer. The tips and skills presented can be applied immediately and will be evident in the very first document that you write after this virtual seminar.


  • 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 organizing, writing, editing, and proofing documents & correspondences
  • 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
    • Active and passive voice
    • Misconceptions and ambiguities
    • Antecedents
    • Knowing the Audience
    • Analyzing the audience
    • Analyzing 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
    • Assessing and writing to the audience to produce effective written correspondence
    • Effective techniques for extracting information from SMEs
  • 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
  • Final Document - Editing basics
    • 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
  • Special considerations:
    • Investigations
    • Submissions
    • Procedures
    • etc.
  • Module 6 Summary
    • Writing submissions - structure and techniques
    • Writing investigations

Who Will Benefit:
  • Anyone in the life sciences that is tasked with writing technical material to include standard operating procedures and work instructions

Speaker Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

He has dedicated his entire professional career explaining the benefits of performance-based training

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