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      Technical Writing for Pharma, Biotech and Med Devices in Boston

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      June 11, 2020

      Thursday   8:00 AM - 4:30 PM (daily for 2 times)

      Boston, Massachusetts 02101

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      Technical Writing for Pharma, Biotech and Med Devices

      Technical Writing for Pharma, Biotech and Med Devices
      About this Event


      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
      Seminar Fee Includes:


      AM-PM Tea/Coffee

      Seminar Material

      USB with seminar presentation

      Hard copy of presentation

      Attendance Certificate

      $100 Gift Cert for next seminar

      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

      DAY 01(8:30 AM - 4:30 PM)

      08:30 AM – 08:59 AM – Registration Process, Meet & Greet

      9:00 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


      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(8:30 AM - 4:30 PM)

      8:30 AM - 8:59 AM Attendees arrive

      9:00 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

      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


      Mark PowellDirector, Mark Powell Scientific Limited

      Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for method development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programs as well as establishing collaborations with academia and instrument manufacturers. His work resulted in a number of published papers and presentations at international scientific conferences. In 2013, he set up his own company to provide training and consultancy services to pharmaceutical professionals. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programs and conducting data integrity audits. He is in demand as a trainer in topics such as chromatography, spectroscopy, pharmaceutical dissolution testing, data integrity, control of impurities, stability/stress studies and sample preparation, as well as technical writing.

      Cost: $2,299 – $13,394

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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