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
Scientific writing
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
Statistical methods
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
Graphical representation of data
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®
Writing effective procedures
Definitions of a Standard Operating Procedure (SOP)