Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

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.

• 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

• 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

• Scientists, engineers, and technicians in research and development
• Quality assurance (QA)
• Information technology (IT)
• Manufacturing
• Other operations professionals
• Administrative staff that must prepare documentation in support of R&D and operations activities
• 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

Instructor Profile:

Joy McElroy

Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy 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.