Technical Writing Skills for Deviations and Investigations

This training programme uses a structured six-step approach to creating high-quality professional deviation and investigation reports. It combines expert input with interactive writing exercises to help learners build confidence and improve their practical skills. 

Key modules include: 

• Writing for the Audience: Communicating with clarity, using the Outside-In approach, adapting to the auditor’s perspective and making effective word choices 
• Writing Problem Statements: Structuring issues using the What, Where, When, Who and How approach, with risk communication and containment actions 
• Defining the Root Cause: Using Root Cause Analysis (RCA) tools such as Fishbone and 5 Whys to document and rationalise root cause findings 
• Identifying Verifiable Corrective Actions: Ensuring corrective actions address root causes (not symptoms), are implementable and can be measured for effectiveness 
• Applying Learning to Other Documents: Extending skills to procedures, memos, change controls and work instructions 

The training involves practical exercises covering all the above topics, with learners encouraged to work on examples from their own workplace. If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting. 

At the end of the course, learners create a prioritised list of key takeaways and commit to applying these principles when writing deviation and investigation reports. 

The training is particularly beneficial for: 

• Technical personnel in production and laboratory environments 
• Quality and compliance staff 
• Auditors and those preparing for inspections 

A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of the training programme, learners will be able to: 

• Analyse the audience to ensure that reports contain meaningful information 
• Write clear and measurable problem statements 
• Document actionable and evidence-based root causes 
• Present logical, structured investigation reports 
• Record verifiable corrective actions and containment activities 
• Identify and structure a clear message for each paragraph 
• Apply the learning to other technical documents, such as procedures, memos and change controls 
• Edit and proofread with confidence to achieve document accuracy 
• Apply practical techniques to reduce errors and improve formatting 
• Produce professional, high-quality reports that engage the reader 

These outcomes ensure that learners return to the workplace with the practical skills and knowledge necessary to create reports that are concise, accurate and audit-ready. 

The course is delivered by experienced industry professionals with expertise in communication, technical writing and training. Each tutor brings practical experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Learners benefit from expert guidance, ongoing support and practical insight throughout the programme. 

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  Gerry Burke

  Gerry is a self-motivated medical industry professional with kn...

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• 

  Ita Lafferty

  Ita Lafferty is a Trainer and Consultant with over 25 years exp...

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• 

  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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• Practical, highly interactive, discussion-based training, with flexibility to meet specific organisational needs 
• Pre-training consultation for in-company courses to tailor content to organisational needs 
• Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Live training is available virtually or delivered on site to suit the needs of the team 
• Real-time support from expert tutors 

Class sizes are limited to 12 participants to support personalised learning and individual support. 

Learners who complete this course often continue to deepen their skills in: 

• Mastering CAPA in the Medical Device Industry 
• Mastering CAPA in the Pharmaceutical Industry 
• Medical Device Risk Management and ISO 14971:2019 
• Pharmaceutical Quality Risk Management and ICH Q9 
• MDSAP Internal Quality Auditor