Technical Writing for the Regulated Industries

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Why You Should Attend:

This course will address how to write effective correspondence and reports in support of your company’s activities. Attendees will learn how to organize and deliver information for the intended audience. They will also learn how to write clear and readable documents, and how to revise and refine your own and others’ writing. The course will provide an overview of sound grammatical conventions, address problematic areas of the English language, and afford opportunities to address specific language issues.

Learning Objectives:

  • Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
  • Know how the reporting process supports products in research, development, and the marketplace
  • Understand how documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final study report
  • Know how to produce effective written correspondence
  • Understand how to assess and write to the audience
  • Know how to organize and deliver information based on the message
  • Understand how to structure reports
  • Understand the innate structures of English grammar
  • Know how to create grammatically sound passages
  • Understand how the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
  • Have a working knowledge of punctuation marks and their role in making documents readable
  • Know how to review and revise documents
  • Understand your own writing patterns and know the answers to your questions about the English language
  • Have increased confidence in writing and revising documents
Areas Covered in the Session :

  • Mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
  • How the reporting process supports products in research, development, and the marketplace
  • How documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final study report
  • Assessing and writing to the audience to produce effective written correspondence
  • How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
  • Reviewing and revising documents
  • Writing patterns and knowing the answers to your questions about the English language
Who Should Attend:

  • Research and Development Departments
  • Quality Assurance Departments
  • Information Technology Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Anyone who wants an in-depth and comprehensive overview of the structure of the language and writing within the broad range of reporting that the industry requires

FDB2554

Joy McElroy

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.