Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries

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This is a Core Course for the following Certification Track(s):

  • Certified Medical Writing Professional (CMWP)™

  • COURSE DETAILS

    Course Description

    Course notes and interactive exercises address how to write effective correspondence and reports in support of the 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.

    Who Should Attend

    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.

    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

    Past Participants' Comments

    "This is the third consecutive course I’ve taken with CfPIE over the last three years. I have yet to be disappointed! The Course Director was great and I’ll definitely use what I learned in my job." Saritha D., Sr. Regulatory Specialist, Pfizer
    "Ms. Gough was a very engaging instructor. The course information she presented will be helpful to me in my current position and future endeavors. I would recommend the Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries course to anyone who does any writing, whether manager or technician." Jon C., Sr. Manager of Quality/Development, Scholle Chemical
    "I really enjoyed this course. It provided very useful information to help me improve my writing and recognize and correct problems in documents I review for others. The instructor was quite knowledgeable and open to sharing her love of language. This was so refreshing in a world becoming so casual in communication, especially the written word." Rick J., Document Management Specialist, Fujifilm Diosynth Biotechnologies
    "This course was to the same high standard that I find refreshing and I appreciate that all courses are excellent. I hope to use your company again and would recommend your courses to colleagues and co-workers." Rachal McK., Compliance Professional, Allergan Pharmaceutical Ireland, Botox Facility
    "I have learned a lot from the Course Director. A very helpful person and explained things very well. I would love to do the SOP Writing course and many more courses with CfPIE." Catherine H., Document Specialist, Pfizer
    "Outstanding course and an outstanding presenter. The course director did a great job." Tim A., Engineer, Guidant
    "The course director did a very good job. This course helped me to realize many things that I do while I write. I now have tools to change some of them. The course director’s way to teach and talk about writing was very different and unusual for me. It makes me think and ask myself good questions. Good job! Even the food was good and all was well planned and organized. Great!" Marie F., Technical Writer, Institut Rosell-Lallemand
    "The modules and hands-on experience were very helpful. The course director’s knowledge in the industry was also great." Maria R., QA Associate, Alza
    "The Course Director has a complete knowledge of the subject. I enjoyed it tremendously and I look forward to more trainings with her." Camille S., Staff Engineer, Cordis
    "I really enjoyed this course. As English is not my native language, it was very useful to refresh on grammar I had learned many, many years ago. In addition, the Course Director covered topics on writing for regulatory submissions, which is very relevant to my current work. I also found her encouraging, because she stated that writing is a skill you can learn, not a talent. This gives me hope that one day I will master English and technical writing. Thanks!" Cyorgyi T., Senior Scientist, Intercytex Manchester, UK

    Frequently Asked Questions

    When writing a GLP study report, can we copy the study plan from the protocol and insert it into the document?

    Many companies “cut and paste” from the protocol, but without adjustment in tense, they risk creating confusing documents. The protocol reflects what a company plans to do; the study report tells what happened during the study and what the outcome is. Thus, it’s important that the study report describes the plan in the past tense, not the future, reflecting what has already occurred.

    We believe we are always objective in our CAPA summaries when stating what happened, but FDA cited our documentation for being unclear in who did what. How can we be more precise?

    There is a conception that scientific writing must be in the passive voice to be objective, but in certain types of documentation, such as CAPA summaries, the passive voice can permit the omission of critical information. Consider the following:

    A package of X was returned to the retail point of purchase. Via telephone, the package was reported to contain loose white powder with the tablets, and the package was sent back to manufacturing the following day.

    Using the active construction necessitates an agent of action, and there’s no doubt as to who did what.

    A pharmacist reported, via telephone, that a customer had returned a package of X because of loose white powder with the tablets in the package. The call center requested return of the package, and the pharmacist shipped it the next day.

    So much of what we write involves comparisons between test groups, but our comparisons don’t seem as clear as they should be. How can we improve?

    Making comparisons and assessing variations and differences are integral to the development of most therapeutic products. Where writers frequently fall short is failing to compare the right things. Consider this sentence: Residue in the liver of the hamster was greater than in the rat. A sentence like this says that the comparison was between residue in liver of the hamster and residue in the entire rat. An easy fix is to recast such a sentence as follows: Liver residue was greater in the hamster than in the rat. Here’s another example of the same sort of illogic: The results of this study are similar to the last study. Careful writers compare results to results, as in the following sentence: The results of this study are similar to those of the last study.

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