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Biotech Courses, CGT Courses, Manufacturing & Quality, Medical Device & IVD Courses, Pharmaceutical Training Courses, Technical Skills
Technical Writing for Pharmaceutical Professionals
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Develop the skill and competence to write technical reports in the pharmaceutical, biopharmaceutical and medical device industries
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Post Learning Implementation Plan (PLIP)
Pre-course
- Access to the Educo Training Portal
- Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
- At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Day 1
9:00 – 16:00
Regulatory expectations
- ICH, US FDA and EMA guidance on eCTD submissions
- How much information to include
Introduction to Technical Writing
- Importance of technical writing: knowledge management and regulatory considerations
- Essential elements of good reports
- Qualities required of technical authors
- Writing appropriately for the audience
- The report writing process
Brevity and clarity
- Importance of brevity
- Examples of common superfluous words and phrases
- Clarity
- Avoiding jargon
- Word order and comprehension
- Explaining context
- Avoiding ambiguity
Report structure
- Planning the report’s structure
- Use of templates
- Typical sections in a technical report
- Appendices and footnotes
- Citing scientific literature
- Designing structure to fit contents
- Approaches for simple and complex reports
- Example
Conventions in scientific writing
- Passive vs. active voice
- Personal vs. impersonal
- Formal vs. informal
Common mistakes in written English
- Plural agreement
- Commonly confused words
- Use of capital letters
Paragraphs and sentences
- Definitions
- Essential elements of a correct sentence
- Sentence/paragraph length
- Punctuation
Abbreviations
- Common abbreviations
- Abbreviating SI units – rules
- Introducing unfamiliar abbreviations
Day 2
9:00 – 16:00
Statistical methods
- Types of data distribution
- Basic statistical terms and techniques
- Tests for normality
- Outliers
- Analysis of variance
- Introduction to experimental design
Presenting data
- Options for presenting data in technical documents
- Designing effective figures and tables
- Types of graph and when to use them
- Use of error bars
- Graphics tools in Microsoft Excel
- Examples
Representing processes
- Input/output diagrams
- Block diagrams
- Flow charts/decision trees
- Swim-lane diagrams
Writing effective procedures
- Differences in style between technical reports and procedures
- SOP structure
- Developing an effective procedure – risk-based approach
- Use of diagrams and pictures
- Procedure lifecycle management
- Regulatory observations
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.
In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.
Mark has delivered many training courses on technical writing; he was responsible for training his team whilst in industry and has continued to train professionals as a consultant. He has trained both English speaking and non-English speaking people, helping them master technical report writing so they can create concise and meaningful reports. Mark draws on his extensive experience of technical report writing and provides multiple examples throughout the course.
This course is aimed at professionals who write and maintain technical reports in the pharmaceutical, biopharmaceutical and medical device industries. These include:
- Regulatory Affairs Professionals
- Any Technical Professionals
- Documentation Personnel
- Project Managers
- Quality
