2021 - Technical Writing for Pharma, Biotech and Medical Devices

Day 01(10:00 AM to 5:00 PM EDT)
10:00 AM -10:30 AM
Regulatory expectations
ICH, US FDA and EMA guidance on eCTD submissions
How much information to include
10:30 AM -10:45 AM Break
10:45 AM -12:00 Noon
Writing appropriately for the audience – who will read your report?
Organization and structure of technical reports
Use of templates
Conventions and style in scientific writing
Correct use of English
Length and structure of sentences
Citing scientific literature
Exercise: identifying and correcting poor writing
12:00 Noon -1:00 PM Lunch
1:00 PM -3:00 PM
Statistical methods
Types of data distribution
Basic statistical terms and techniques
Tests for normality
Outliers
Analysis of variance
Introduction to experimental design
Exercise: using appropriate statistical techniques
3:00 PM - 3:15 PM Break
3:15 PM - 4:30 PM
Graphical presentation of data
Options for presenting data in technical documents
Designing effective figures and tables
Use of error bars
Graphics tools in Microsoft Excel®
Exercise: selecting appropriate data presentation methods
Day 02(10:00 AM to 5:00 PM EDT)
10:00 AM -10:30 AM
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
Exercise: reviewing a SOP
10:30 AM -10:45 AM Break
10:45 AM -12:00 Noon
Workshop/group exercise: review of example reports – identifying good and bad practice
12:00 Noon -1:00 PM Lunch
1:00 PM -3:00 PM Report-writing workshop
3:00 PM -3:15 PM Break
3:15 PM -4:15 PM Report-writing workshop (continued)
4:15 PM -4:30 PM Final questions, feedback and close