3 Hours Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Joy L. McElroy

Starting at

$329

Premier price: $296 (save 10%)

Single registration

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Reasons To Attend:

You should attend this course because it addresses how to write effective correspondence and reports in support of your company's activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues.

Areas Covered:                                    

  • 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

 

Learning Objectives:

Upon completion of this course, you will:

  • 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

Target Audience:

Scientists, engineers, and technicians in research and development will find this course valuable, as will quality assurance (QA), information technology (IT), manufacturing, and other operations professionals. This course is also useful for administrative staff that must prepare documentation in support of R&D and operations activities. Additionally, the course is helpful for 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.

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Premier price: $ 719 (save 10%)

Recorded video

Recorded video session

Premier price: $ 494 (save 10%)


Speaker: Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.