3-Day Virtual Seminar - Technical Writing for Pharma, Biotech and Med Devices (ONLINE EVENT: November 16-18, 2026)

This 3-day virtual seminar provides a comprehensive, structured approach to technical writing in the life sciences, progressing from foundational principles to applied writing techniques across multiple regulated document types.

Included with Registration

Presentation Slides
Certificate of Completion
Live Q&A with Expert
16 hours of Continuing Education
Case Studies
Real-World Examples

Course Content

Day 1 - Foundations of Technical Writing in the Life Sciences

The seminar begins with a clear definition of technical writing and its critical role within regulated environments. Participants will explore:

Types of documents used in the life sciences
Regulatory expectations for documentation
The consequences of poor writing
Characteristics of effective vs ineffective documents

This day establishes the “why” and “what” of technical writing and introduces the core principles that guide all subsequent content.

Day 2 - Audience, Structure, and Information Development

The second day focuses on how writing decisions are driven by the audience and the intended use of the document. Participants will learn how to:

Analyze audience capability and needs
Determine appropriate level of detail and language
Structure documents for usability and compliance
Organize content logically and consistently

Special emphasis is placed on document architecture, ensuring that content is not only correct - but usable in real-world operations.

Day 3 - Working with SMEs and Writing Regulated Documents

This day focuses on the most challenging aspect of technical writing - extracting accurate information and translating it into clear documentation.
Participants will learn:

Techniques for interviewing and working with SMEs
How to observe and document processes effectively
Strategies for managing conflicting input

Writing approaches for specific document types such as:

Investigations
Procedures and work instructions
Regulatory submissions

This day emphasizes accuracy through collaboration and introduces real-world writing scenarios.

Writing Mechanics, Simplification, and Finalization

The final day addresses the mechanics of writing and the process of producing a finalized, inspection-ready document.
Topics include:

Grammar, punctuation, and consistency rules
Active vs passive voice
Eliminating ambiguity and misconceptions
Writing simplification techniques
Reviewing, editing, and incorporating comments
Managing document approval and timelines

Participants will leave with a complete understanding of the end-to-end writing lifecycle, from concept to final approved document.

3 Day Agenda

This seminar will address the following across four days:

Technical writing overview and definitions

Role of documentation in life sciences
Regulatory expectations (FDA, ISO, etc.)
Types of technical documents
Audience & Structure

Audience analysis and writing alignment

Document organization and formatting
Consistency and style standards
Writing for non-native audiences
Information Development

Working with subject matter experts

Techniques for extracting accurate information
Observational documentation methods
Managing conflicting inputs
Writing Techniques

Grammar, spelling, punctuation

Numbers, symbols, and formatting
Active vs passive voice
Eliminating ambiguity and misconceptions
Antecedents and clarity
Document Types

SOPs and work instructions

Investigations and deviations
Regulatory submissions
Reports and summaries
Review & Finalization

Editing and proofreading techniques

Incorporating reviewer comments
Managing review cycles
Negotiating reviewer disagreements
Final approval process
Regulatory Alignment

FDA expectations for documentation quality

Writing for inspections and submissions
Responding to regulatory requests

Speaker

Charles H. Paul (25+ yrs exp.)

Who Should Attend

Anyone in the life sciences that is tasked with writing technical material to include standard operating procedures and work instructions
Functions - engineering, research & development, compliance and regulatory, operations, analytical, logistics/supply chain, training & development and technical services
Titles - associates, supervisors, managers, associate directors, directors

License	Format	Properties	Price
ONE DELEGATE Online Access (Recorded)	The recorded training can be accessed through a secure website. Username and password will be sent via email.	This is a single delegate licence. This allows access for one delegate.	€1284EUR$1,395USD£1,072GBP
ONE DELEGATE Online Access (Live)	The training can be accessed live through a secure website. Username and password will be sent via email.	This is a single delegate licence. This allows access for one delegate.	€1334EUR$1,450USD£1,114GBP
1 - 5 DELEGATES Online Access (Recorded)	The recorded training can be accessed through a secure website. Username and password will be sent via email.	This is a 1-5 delegate license, allowing access for up to five delegates.	€3676EUR$3,995USD£3,070GBP
1 - 5 DELEGATES Online Access (Live)	The training can be accessed live through a secure website. Username and password will be sent via email.	This is a 1-5 delegate license, allowing access for up to five delegates.	€4596EUR$4,995USD£3,839GBP

Included with Registration

Course Content

Speaker

Who Should Attend

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