Training | Consultancy | Auditing 

Technical Writing for Regulated Environments 

An expert approach to writing technical documents is an expectation in many industries.  
This course will build and enhance your existing knowledge around Effective Communication.  
The Why? What? Who? When? Where? How? of technical writing.  
 
Planning a document from the beginning, plain English concepts and the use of templates will be addressed along with Technical Procedures and Technical Reports. 
Whether you are researching, writing reports, procedures, proposals, emails, letters, memos, presentations (to mention some) this course will help you understand your audience, the purpose and context of your writing. 
 
Purpose, audience, planning, clarity, ambiguity, plain English and inspection-ready sentence construction. 
GMP/regulatory context, auditor expectations, deficiency thinking, SOP and deviation rewrite practice, and documentation decisions that stand up to scrutiny. 
Delivery style: short tutor inputs, small-group rewrites, peer critique, discussion and debrief. Minimal lecture. 
Delegates submit a report / SOP, GMP document to the tutor within 10 working days for 1:1 feedback. 
Book today and get free access to our Self-Directed Learning "Pre-Requisites" Technical Writing Basics  
€495 
Technical Writing for Regulated Environments 
 
This course is designed for those that work in, or write documents and reports for either regulatory, certitication or nofitied bodies. 
At the end of the training delegates will have enhanced their skills and techniques to: 
 
• Write clear, concise, audience-centered content; 
 
• Understand the writing process and the importance of effective technical writing; 
 
• Plan and structure documents from beginning to end; 
 
• Design and use templates; and 
 
• Create, edit, review and approve technical documents. 
 
 
Course Outline / Summary 
Technical Writing as a Regulatory Control 
Dealing with Ambiguity 
The Five Ws and H: Planning & Spotting Ambiguity 
The Writing Process 
The 6 Cs as a Review Tool 
SOP Through the Auditor’s Lens 
Regulatory Documentation Across the Product Lifecycle 
Deviations, Investigations and CAPA 
Regulatory Deficiencies Review 
AI in Technical Writing 
Book your course today and get free access to our self paced "pre-requisites" technical writing basics  
 
Technical Writing for Regulated Environments 
€495 
Note 
For those NOT working in regulated industries and who just want to improve their technical writing we offer private bespoke courses to best suit your needs. 
Please contact us today today to disucss further 

Testimonials 

The 2 days went really quickly - Fergal was excellant - so positive and helpful and has amazing experience. 
 
Orla McKiernan - Griffith College 
Going into the course I wouldn't have been confident to complete an audit myself but leaving the course I felt I could confidently complete an internal or external audit. 
 
Michelle - TCFG 
Overall experience was great, I learned a lot from this course. Style, technique and content were helpful in terms of building Audit experience. 
 
Marwan Redha - Medtronics