Recording
Recording

2-Day Seminar Recording | Course Director: CHARLES H. PAUL


$1999 
  • SKU: SEM3567

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PRE-REGISTRATION AVAILABLE 

If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.

Pre-Register now and pay only once the training is scheduled on your preferred days.


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.

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.


SEMINAR OBJECTIVES
WHO SHOULD ATTEND
  1. Define technical writing
  2. Determine the role technical writing plays in the life sciences
  3. Explain what technical writers in the life sciences write
  4. Explain how technical writers effectively analyze their audience
  5. Explain how information is gathered from subject matter experts
  6. Explain how writers plan the content
  7. Explain how non-native speaking audiences are handled
  8. Explain the most effective way to simplify your technical writing
  9. Explain how accuracy is assured in technical writing

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Operations Departments
  • Research and Development Departments
  • Production Departments
  • Manufacturing Departments
  • Engineering Departments
  • Analytical Professionals
  • Logistics/Supply Chain Departments
  • Training & Development Departments
  • Technical Services


AGENDA

DAY 1 (11 AM to 3 PM)

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.

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

Module 3: Knowing the Audience
- Analysing 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
- 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



DAY 2 (11 AM to 3 PM)

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

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

Module 6: Summary
- Q/A Session with the Course Instructor
- Case study and Many Exercises
- Discuss your current challenges




COURSE DIRECTOR: CHARLES H. PAUL

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm.  Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject.  His firm works with both domestic and international clients designing solutions for complex regulatory, Lean, training, and documentation issues.