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Technical Writing for Pharma, Biotech and Medical Devices

 
  March 06, 2020  
     
 
Compliance Online, Hilton Singapore 581 Orchard Road, Singapore 238883, Singapore
March 30-31, 2020


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.

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

 

 
 
Organized by: ComplianceOnline
Invited Speakers:


Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

 

 
Deadline for Abstracts: 2020-03-17
 
Registration:
 
$1,899.00

Seminar One Registration (USD)

March 30-31, 2020, Singapore
(Registrations till March 6, 2020 - $1899)
(Registrations after March 2, 2020 - $2099)

E-mail: referral@complianceonline.com
 
 
   
 
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