ComplianceOnline and Subject Matter Expert, Mark Powell, will conduct a two day virtual seminar on Technical Writing for Pharma, Biotech and Medical Devices
SAN JOSE, CA, USA, January 22, 2021 /EINPresswire.com/ — The "Technical Writing for Pharma, Biotech and Medical Devices" conference has been added to ComplianceOnline.com's offering.
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
• 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
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.
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 headquartered in Palo Alto, California, and can be reached at http://www.complianceonline.com. 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 or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: January 28-29, 2021 (10:00 AM – 5:00 PM EST)
Register by phone: Please call our customer service specialists at +1-888-717-2436 or email to firstname.lastname@example.org
For more information on ComplianceOnline or to browse through our trainings, please visit our website
Source: EIN Presswire