Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Joy McElroy
  • 10, February 2025 Monday
  • 10:00 AM PT | 01:00 PM ET (120 Min)

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.

Live Online Training
February 10, Monday 10:00 AM PT | 01:00 PM ET (120 Min)

$229.00
One Dial-in One Attendee
$1,299.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Download File Only

(PPT + Recorded Training File)

$399.00
Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You 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 Webinar:
  • 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 Will Benefit:
  • 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:
JJoy McElroy 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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