Technical Writing for Pharma, Biotech and Medical Devices: 2 Day Live Webinar September 9-10
Dublin, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Dr Mark Powell presents a live 2-day webinar, "Technical Writing for Pharma, Biotech and Medical Devices", this coming Thursday & Friday (September 9th to 10th), starting at 10am EDT. Event details found on the above at ResearchAndMarkets.com.
This is a valuable course for those involved in any of:
Regulatory affairs
Project managers
Technical staff with responsibility for report/procedure writing
Quality management
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
Presentations & Timetable:
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
For more information about this event visit https://www.researchandmarkets.com/r/4qk9bh
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