Technical Writing for Pharma, Biotech and Medical Devices

"Technical Writing for Pharma, Biotech and Medical Devices" Seminar has been added to ComplianceOnline.com's offering.

SAN JOSE, CA, UNITED STATES, December 23, 2021 /EINPresswire.com/ -- ComplianceOnline, the leading provider of training for regulated Companies is hosting a seminar ‘Technical Writing for Pharma, Biotech and Medical Devices.’ The seminar will be held on January 26-27, 2022, and presented by Dr Mark Powell, Director, Mark Powell Scientific Limited. Regulatory affairs professionals, project managers, quality managers and technical staff with responsibility for report/procedure writing will greatly benefit from attending this seminar.

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 clearly and concisely. 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.

The event overview states that by the end of the course, attendees will be able to:
• Understand the expectations of regulators when reviewing an 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
• Analyse experimental data using statistical principles

The seminar will cover the following areas
• 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

For more information or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: January 26-27, 2022 (11:00 AM - 5:00 PM EST)

About the Speaker:

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.
About ComplianceOnline.com:

ComplianceOnline is a leading provider of regulatory compliance training programs for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC), and Quality Management Solutions for global corporations.

For more information on ComplianceOnline or to browse through our training programs, please visit our website.

Priyabrata Sahoo
ComplianceOnline
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