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Technical Writing Excellence in the Life Sciences - A Masterclass

June 13 - 14, 2024 | US Eastern Time: 11 AM to 3 PM | Central Europe Time: 5 PM to 9 PM

$1200 
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This virtual seminar will provide a comprehensive discussion of technical writing and its significance in the life sciences industry. Technical writers play a vital role in producing various technical documents that manage and direct regulated operations, ensuring regulatory compliance. In this webinar, we will explore the different document types, their importance, and the consequences of unclear or misunderstood messages.


We will then delve into the technical writing process, beginning with the analysis of the target audience and determining the appropriate writing level to create effective technical documents. Collaboration between the writer and SMEs is crucial for gathering information to be included in technical documents. We will discuss the most effective techniques for extracting information from SMEs and observing procedures and activities to be documented, making the process more efficient and effective.


Finally, we will address the mechanics of technical writing, including content planning and organization, grammar, spelling, punctuation, and simplification of the writing process. This webinar will provide valuable insights to technical writers seeking to enhance their writing skills and create better technical documents, ultimately leading to better regulatory compliance and operational efficiency in the life sciences industry.


WHY YOU SHOULD ATTEND:

Effective communication in the life sciences industry relies heavily on technical writing skills. Technical writers play a crucial role in ensuring that information is conveyed accurately, clearly, and succinctly, as mistakes in technical documents can lead to life-threatening consequences. However, technical writing is often overlooked in college curriculums, leaving life sciences workers to assume the skill without proper training, resulting in mediocre writing that may not convey the intended message.


To help you become a better technical writer, this virtual seminar will guide you through the entire technical writing process, from analyzing your audience to gathering information and organizing content. We will address each critical aspect of technical writing in the life sciences, providing practical tips and skills that you can apply immediately to enhance your writing abilities. By the end of the seminar, you will be equipped with the tools to produce technical documents that are accurate, clear, and effective, ultimately contributing to better regulatory compliance and operational efficiency in the life sciences industry. Don't miss out on this opportunity to improve your technical writing skills and advance your career!

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.