Faculty: Charles H. Paul ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3769


  • Date:05/20/2026 11:00 AM - 05/20/2026 12:00 PM
  • Location Online Event

 

Description

Technical writing in regulated industries—particularly pharmaceuticals, biotechnology, and medical devices—requires precision, consistency, traceability, and compliance with strict regulatory expectations. Documents such as SOPs, clinical reports, validation protocols, and regulatory submissions must not only be accurate but also structured in a way that supports usability under real-world conditions. At the same time, organizations face increasing pressure to produce high volumes of documentation quickly, often with limited resources. This has created a gap between the need for high-quality documentation and the ability to consistently deliver it.

The emergence of tools like ChatGPT introduces a new opportunity to enhance technical writing processes. However, most organizations are still unclear on how to use these tools effectively—especially within regulated environments where data integrity, authorship, and validation concerns must be addressed. This webinar focuses on practical, controlled, and compliant approaches to using ChatGPT as a support tool in technical writing—not as a replacement for human expertise, but as an accelerator for structured, high-quality document development.

| WHY YOU SHOULD ATTEND

There is a growing misconception that AI tools like ChatGPT can simply “write documents” for regulated industries. In reality, without proper structure, oversight, and controls, their use can introduce significant risk—ranging from inaccurate content to compliance issues and loss of traceability. Many organizations are already experimenting with AI-assisted writing, but they are doing so inconsistently. Some teams are using it informally for drafting, others are avoiding it entirely due to perceived risk, and very few have implemented structured approaches that align with regulatory expectations.

This creates a fragmented environment where:

  • Document quality varies significantly between teams 
  • Writing efficiency gains are inconsistent or unrealized 
  • Concerns about compliance and validation remain unresolved 
  • AI outputs are not standardized or controlled 
  • Opportunities for productivity improvement are missed 

The reality is that ChatGPT can significantly enhance technical writing—if used correctly. It can help structure content, improve clarity, reduce redundancy, and accelerate drafting. But it must be integrated into a controlled workflow that maintains human oversight, ensures accuracy, and aligns with regulatory requirements. Without a defined approach, organizations risk either underutilizing a powerful tool or misusing it in ways that compromise document quality and compliance. This webinar provides a practical framework for using ChatGPT in technical writing environments, focusing on how to leverage its strengths while maintaining control, accuracy, and regulatory alignment. If your organization produces SOPs, validation documents, regulatory submissions, or technical reports, this session will help you understand how to safely and effectively incorporate AI into your writing process.

| AREAS COVERED

  • Role of AI in technical writing for regulated industries 
  • Capabilities and limitations of ChatGPT 
  • Developing effective prompts for structured outputs 
  • Using ChatGPT for SOP drafting and document development 
  • Converting notes and legacy content into formal documentation 
  • Improving clarity, readability, and usability of technical documents 
  • Maintaining accuracy and validating AI-generated content 
  • Ensuring traceability and authorship control 
  • Aligning AI use with ALCOA+ data integrity principles 
  • Integrating ChatGPT into existing documentation workflows 
  • Risk considerations and governance for AI-assisted writing 
  • Best practices for controlled and repeatable use

| WHO SHOULD ATTEND

  • Technical Writers 
  • Regulatory Affairs Professionals 
  • Quality Assurance Specialists 
  • Validation Engineers 
  • Clinical Documentation Professionals 
  • SOP Authors and Reviewers 
  • Project Managers in Life Sciences 
  • Training and Documentation Managers

| TOPIC BACKGROUND

This webinar provides a structured and practical approach to integrating ChatGPT into technical writing processes within regulated environments. Rather than focusing on theoretical capabilities, the session emphasizes how to use AI tools in a controlled, repeatable, and compliant manner. The session begins by establishing the role of ChatGPT in technical writing—not as an author of record, but as a support tool that enhances productivity and consistency. Participants will learn where AI fits within the document lifecycle, including drafting, editing, formatting, and standardization.

From there, the webinar explores how to develop effective prompts that produce structured, usable outputs. This includes techniques for guiding ChatGPT to generate content aligned with SOP formats, regulatory expectations, and organizational standards. A key focus of the session is maintaining control over AI-generated content. Participants will learn how to validate outputs, ensure accuracy, and maintain traceability—critical requirements in regulated environments. The session also addresses how to avoid common pitfalls such as over-reliance on AI, generation of incorrect or unsupported content, and loss of document ownership.

The webinar then moves into practical applications, demonstrating how ChatGPT can be used to:

  • Draft structured SOP content 
  • Convert unstructured notes into formal documentation 
  • Standardize formatting across documents 
  • Simplify complex technical language 
  • Improve clarity and usability of instructions 

Participants will also learn how to integrate ChatGPT into existing workflows without disrupting established quality systems. This includes defining roles and responsibilities, establishing review processes, and ensuring alignment with data integrity principles such as ALCOA+. The session concludes with a discussion of governance considerations, including when and where AI use is appropriate, how to document its use, and how to maintain compliance with regulatory expectations. By the end of this webinar, participants will have a clear, practical understanding of how to use ChatGPT as a controlled tool to improve technical writing efficiency while maintaining the standards required in regulated industries.


Course Director: Charles Paul

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