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

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Course Overview

 

The quality and clarity of written technical documents is important for the success of pharmaceutical companies. Such documents are used in regulatory submissions, to report the outcome of development work to clients, to record the results of investigations and to guide the direction of internal projects. They also act as important repositories of knowledge and often provide useful insights for process and quality improvement.

 

In this training course, you will learn how to analyse and present technical data in a clear and concise manner. The use of visual tools such as graphs and flow charts will be covered, together with the design of effective tables. Statistical tools for data reduction and analysis will also be discussed and the elements of effective procedures and protocols will be explained. After the course, you will have the confidence to tackle technical report writing in the workplace.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver online and classroom training.

Key Learning Objectives

 

  • Understand the appropriate level of detail to include in regulatory submissions
  • Edit documents to remove superfluous words or phrases
  • Identify and correct ambiguous text
  • Write effective technical reports and procedures that cater for the needs of their target audience
  • Present complex experimental data in a logical, clear and concise manner making optimal use of graphs, charts and tables
  • Follow the conventions of scientific writing to support explanations and arguments
  • Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common mistakes in written English
  • Analyse experimental data using statistical principles

What is Included in a Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

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
Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

 

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change.
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.