Effective Technical Writing in the Life Sciences Course Description

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. 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 organising the content through grammar, spelling and punctuation ending with writing simplification.

3 Day Agenda

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.

Break 10 minutes

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

Break 10 minutes

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

Break 10 minutes

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

Break 10 minutes

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

Break 10 mins

Module 6 Summary

·      Q/A Session with the Course Instructor

·      Case study and Many Exercises

·      Discuss your current challenges

·      Award Certificate for the completion of the 3 Day course 

Learning Objective

 An effective technical writer must consider many aspects of the craft to be truly effective. Writers, must adopt and apply the form and style of the industry in which they work as there are differences for example, between the documents written for a pharmaceutical production operation versus the creation of scientific journal articles. Writers must understand their audience in terms of their needs and abilities and the level of explanation that they require as well as their command of the language in which the material is written. They must have a complete and unwavering dedication to accuracy and consistency. Technical writers must understand and be skilled at collaboration as that is how accuracy is achieved – by harvesting information from subject matter experts.

Why Should You 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. 

 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 3 Day 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.

Who Should Attend Technical Writing Course

Anyone in the life sciences that is tasked with writing technical material to include standard operating procedures and work instructions . This course will benefit professionals from new joinees to managers in the pharmaceutical, medical device, biologics and related health industries who would like to write more effective documents

Job Functions

Engineering

Research & development Compliance

Regulatory

Operations

Analytical

Logistics/Supply chain

Training & Development

Technical Services.

Job Titles – Associates, Supervisors, Managers, Associate Directors, Directors , Clinical Research, Scientists etc.

FDA Faculty Charles H. Paul

Faculty Charles H. Paul 

President at C. H. Paul Consulting LLC

Tobyhanna, Pennsylvania, United States

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

The firm works globally completing projects throughout the EU, UK, South America, and Asia.


Choose a Purchase Option


$1,950

Early bird Live - Single Participant + 90 days On Demand access Free

3 Days Virtual Seminar

You get one log-in for the live 3 Days Virtual Seminar for one participant, presentation materials and the opportunity to ask questions by phone and email.

$3,995

Group-Max. 5 Attendees - Live + 6-month On Demand Access

You get Group log-in for the live virtual seminar for 5 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 6 month for the Group.

$1,899

Corporate Recorded Access

You'll have 6-month access to single log-in for an archived recording of the entire 3 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Our Past Seminar Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals