$1,495
Early Bird One Dial-in One Attendee - Live
One log-in for the live 3-day virtual seminar for one participant.
- One attendee log-in
- Live 3-day virtual seminar
- Presentation materials included
- Certificate included
- Ask questions by phone and email
Purchase Options
Technical Writing Course Registration
Choose live virtual training or 1-year on-demand access for the 3-day course.
$4,995
Live Group up to 2-5 Participants
2-5 log-ins for the live 3-day virtual seminar for all participants.
- 2-5 participant log-ins
- Live 3-day virtual seminar
- Presentation materials included
- Certificates included
- Ask questions by phone and email
$1,498
Simulation Live - 1 Year Single User On Demand Access
12-month single-user access to the archived recording of the full 3-day seminar.
- Single-user access
- 12-month recording access
- Q&A period included
- Presentation materials included
- Access any time of day or night
$4,498
Simulation Live - 1 Year Group 2-5 On Demand Access
2-5 log-ins for group access with materials and certificate of completion.
- 2-5 participant access
- 1-year group on-demand access
- Presentation materials included
- Certificate included
- Ask questions by phone and email
Technical Writing for FDA-Regulated Industries
This three-day seminar provides practical guidance on developing clear, accurate, consistent, and compliant technical documentation for pharmaceutical, biotechnology, and medical device industries. The program combines technical writing fundamentals with current FDA, ISO, ICH, and EU GMP documentation expectations.
Day 1
Technical Writing Fundamentals, Regulatory Requirements & Writing Techniques
1. Foundations of Technical Writing and Regulatory Documentation
- Technical writing principles, definitions, and essential characteristics
- Role and importance of documentation in regulated life-sciences industries
- Regulatory requirements and industry standards:
- FDA cGMP requirements under 21 CFR Parts 210 and 211
- FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, and ISO 13485:2016
- 21 CFR Part 11: Electronic Records and Electronic Signatures
- EU GMP Chapter 4: Documentation
- ICH Q9(R1): Quality Risk Management
- ICH Q10: Pharmaceutical Quality System
- Good Documentation Practices (GDP) and ALCOA principles
- Types, purpose, and intended use of regulated technical documents
- Document relationships, traceability, and consistency throughout the product lifecycle
2. Audience, Document Structure and Information Development
- Identifying the intended audience and adapting writing accordingly
- Writing for technical, non-technical, and cross-functional audiences
- Using appropriate terminology, acronyms, and definitions
- Organizing information logically and consistently
- Developing standardized document formats, templates, and style conventions
- Writing effective headings, sections, and document summaries
- Using tables, figures, diagrams, and references to communicate technical information
- Working with subject matter experts (SMEs) to obtain accurate technical information
- Interviewing, extracting, and verifying information; observational documentation methods
- Managing conflicting inputs and resolving technical inconsistencies
3. Writing Techniques and Documentation Quality
- Grammar, spelling, punctuation, and professional writing conventions
- Constructing clear, concise, and technically accurate sentences
- Appropriate use of active and passive voice in regulated documentation
- Eliminating ambiguity, assumptions, and misleading statements
- Writing clear instructions, descriptions, and definitions
- Presenting cause-and-effect relationships and chronological sequences
- Using numbers, symbols, abbreviations, and units consistently
- Maintaining clarity, readability, and consistency across documents
- Avoiding common technical writing errors and documentation deficiencies
Day 2
Writing and Managing Regulated Industry Documents
4. Writing and Managing Regulated Industry Documents
- Preparing and revising Standard Operating Procedures (SOPs)
- Writing work instructions, policies, and technical procedures
- Documenting deviations, nonconformances, and quality events
- Writing investigation reports with objective evidence and clear conclusions
- Documenting root cause analysis (RCA) and corrective and preventive actions (CAPA)
- Preparing change control documentation and impact assessments
- Writing validation protocols, reports, and supporting technical documentation
- Preparing laboratory, manufacturing, and quality reports
- Writing regulatory submissions, responses, and supporting technical summaries
- Maintaining consistency, traceability, and cross-references between related documents
5. Data Integrity, Electronic Documentation and Regulatory Expectations
- Applying ALCOA principles to paper-based and electronic records
- Ensuring records are attributable, legible, contemporaneous, original, and accurate
- Documentation practices for data integrity and record reliability
- Electronic records, electronic signatures, and 21 CFR Part 11 expectations
- Document version control, revision history, and audit trail considerations
- Maintaining complete, accurate, and retrievable records
- Documentation expectations under FDA QMSR and ISO 13485:2016
- Preparing documentation for FDA inspections and regulatory audits
- Documentation for management reviews, internal audits, and supplier audits
- Responding to regulatory observations, information requests, and documentation gaps
Day 3
Document Review, Inspection Readiness & Practical Writing Workshops
6. Document Review, Editing and Finalization
- Effective editing, proofreading, and technical review techniques
- Reviewing documents for accuracy, completeness, consistency, and compliance
- Incorporating SME and reviewer comments
- Managing review cycles, version changes, and document revisions
- Resolving conflicting reviewer feedback and negotiating disagreements
- Document approval, authorization, and controlled release
- Document retention, retrieval, and lifecycle management
- Measuring document quality and managing review and approval timelines
7. Practical Technical Writing Workshops
- Reviewing and improving a poorly written SOP or work instruction
- Rewriting ambiguous statements into clear, actionable instructions
- Preparing a structured deviation or investigation report
- Improving root cause and CAPA documentation
- Reviewing technical reports for accuracy, completeness, and traceability
- Identifying data integrity and documentation weaknesses in sample records
- Incorporating reviewer comments and finalizing revised documents
- Addressing participants’ real-world technical writing challenges
8. Emerging Developments in Regulated Documentation
- Evolving expectations for electronic documentation and digital quality systems
- Regulatory developments affecting GMP documentation and computerized systems
- Proposed revisions to EU GMP Chapter 4 and Annex 11, and proposed new Annex 22 on Artificial Intelligence
- Responsible use of AI-assisted writing and document review in regulated environments
- Human review, verification, accuracy, and accountability when using AI-generated content
- Future trends in technical writing and documentation management in life-sciences industries
Effective Technical Writing Course Description
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
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.
Learning Objective
At the completion of this seminar, you will be able to:
- Execute a structured technical writing process from start to finish
- Analyze audience needs and tailor documentation accordingly
- Develop clear, accurate, and compliant technical documents
- Apply effective techniques for working with SMEs
- Write and structure SOPs, investigations, and submissions
- Identify and correct common writing errors and ambiguities
- Apply simplification techniques to improve usability
- Manage document review, revision, and approval processes
- Align documentation practices with regulatory expectations
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
Functions – engineering, research & development, compliance and regulatory, operations, analytical, logistics/supply chain, training & development and technical services.
Titles – associates, supervisors, managers, associate directors, directors
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Faculty Charles H. Paul ( 25+ yrs exp.)
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.
