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 ExcelÂ® 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.
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.
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.
Dr Mark Powell
Dr Mark Powell is a UK-based provider of auditing, training and consultancy services to the pharmaceutical industry. He set up his own business in 2013, having worked as both Analytical Manager and Scientific Manager for a pharmaceutical manufacturer.
He is accredited as a training provider by Cogent Skills, the UK’s strategic body for training in the science industries. A Fellow of the Royal Society of Chemistry, he is an experienced trainer in the area of pharmaceutical quality systems. He has written and delivered many pharmaceutical training courses and specializes in QC laboratory auditing and pharmaceutical data integrity. He is regularly asked to speak at scientific meetings and is the author of over 30 scientific papers and conference presentations.
Dr Powell is currently Honorary Treasurer of the Royal Society of Chemistry’s Analytical Division and leads a RSC working group on continuing professional development.