Technical Report Writing And Statistical Analysis For The Pharmaceutical Industry

Category: Technical Report Writing And Statistical Analysis For The Pharmaceutical Industry

Course Description

Clear, unambiguous technical reports and procedures are of vital importance in the pharmaceutical industry. They are used to communicate the outcomes of product development work and investigations, and may be reviewed by the FDA, or other regulatory bodies, if they form part of a regulatory submission. On this course, participants will learn how to analyze and present technical data in a clear and concise manner. They will produce powerful charts and graphs using the graphics tools in Microsoft Excel® and will design compelling tables making data comparison a powerful tool for the target audience. Important statistical methods such as evaluation of outliers, analysis of variance, experimental design and estimation of uncertainty will be covered. The elements of effective standard operating procedures will also be explained.

Course Methodology

The material used in the training course will be based on exercises as well as regional and international case studies. Participants will frequently work in pairs as well as in larger teams.

Participants will have the opportunity to practice their new set of skills in technical report writing. They will be given the option to work on a report using data from their workplace or use model data supplied by the trainer.

Course Objectives

By the end of the course, participants will be able to:

  • Write effective technical reports and procedures that cater to 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
  • Build credibility by following the conventions of scientific writing to support explanations and arguments
  • Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common written English mistakes
  • Analyze experimental data using the principles of statistical analysis

Target Audience

This course is designed for pharmaceutical professionals tasked with data analysis and/or producing technical reports and procedures. It will be particularly beneficial for research and development (R&D) analysts/ managers, scientists, engineers, and technicians as well as Quality Assurance (QA), Information Technology (IT), manufacturing, and other operations professionals. This course will also prove useful for administrative staff supporting the R&D and operations activities by preparing technical documentation.

Target Competencies

  • Technical Procedure Writing
  • Technical Report Writing
  • Statistical Analysis
  • Technical Data Presentation
  • Technical Language

Course Outline

  • Organization and structure of technical reports
  • Conventions and style in scientific writing
  • Correct use of English
    • Common mistakes
    • Verbs, nouns, prepositions and adjectives
    • Punctuation
  • Length and structure of sentences and paragraphs
  • Figures and tables
  • Citing scientific literature
  • Distributions and types of data
  • Basic statistical techniques
  • Outliers
  • Analysis of variance
  • Experimental design
  • Estimates of measurement uncertainty
  • Rules governing the use of statistical techniques in pharmaceutical QC
  • Options for presenting data in technical reports
  • Designing effective tables
  • Optimal types of graphs
    • Scatter graphs: linear and non-linear
    • Pie charts
    • Bar/column graphs
    • Radar plots
  • Use of error bars
  • Graphics tools in Microsoft Excel®
  • Definitions of a Standard Operating Procedure (SOP)
  • Best practice in SOP writing
  • The importance of brevity and clarity
  • Organization and structure of a SOP
  • Use of figures and diagrams
  • Point-of-use aids to compliance