Technical Writing for Pharma, Biotech and Med Devices

The quality and clarity of written technical documents is vital to 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. In this course, participants will learn how to analyze 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 covered. The elements of effective standard operating procedures will also be explained. A large part of the course will be spent in a workshop setting, where attendees will produce technical content for comment and evaluation. The workshop can either be based on participants’ own data or model data provided by the trainer.

Attendees will be expected to bring a laptop computer. By the end of the course, attendees will be able to:
Understand the expectations of regulators when reviewing a NDA/BLA/MAA
Edit documents to remove superfluous words or phrases
Identify and correct ambiguous text
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
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
Analyze experimental data using statistical principles
Learning Objectives:
Information required in regulatory submissions
eCTD format and style
The fundamentals of effective writing: accuracy, brevity and clarity
Common mistakes in written English
Effective use of figures and tables
Correct methods of citing literature sources in technical documents
Types of data distribution
Statistical treatment of experimental data
Design of Experiments (DoE)
Writing effective procedures

Who will Benefit:
Regulatory affairs professionals
Project managers
Technical staff with responsibility for report/procedure writing
Quality management