Technical Writing for Pharmaceutical, Medical Device and Biologics Industry

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Jan 26, 2017
90 minutes
Product Description

Gain effective technical writing skills for the pharmaceutical, medical device, and biologics industry

In business, at workplace, and in our personal lives, we all stand to benefit from more effective writing skills. Writing is essential to communicate your message clearly and professionally and to incite action in those who you supervise, work with and require action from. Many in the workforce today struggle with the basics of writing including grammar, spelling and punctuation and that is what can hold them back and reduce their confidence when it comes to business documents. The style and skills required for formal business writing are best developed by practice and experience, but with the right tools and know-how it is not hard to improve.

Join industry veteran Joy McElroy, where she provides tips on how to write effective correspondence and reports in support of your company's activities. Learn how to organize and deliver information for the intended audience; write clear and readable documents; and 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.

Session Highlights

  • 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.

Session Benefits

Upon the completion of the course, participants will be able to:

  • Understand the new FDA perspective of a "Process Validation Life-Cycle" that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness) as stated by the FDA's new Guideline on Process Validation and its impact on how process validation activities are carried out.
  • Understand the perspective of the EMEA, ICH, WHO and PIC/S on process validation and how they can be incorporated into a single process validation system.
  • Set up process validation programs and corresponding documentation including protocols and reports that meet current FDA, WHO, PIC/S and EU regulations.
  • Prepare and defend your own process validation approach/program.

Who should attend?

  • QA and QC managers
  • Quality Engineers
  • Validation managers
  • Validation Engineers and Specialist
  • Operations managers
  • Regulatory compliance managers and personnel

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Joy McElroy

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved 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...   More Info
More Events By The Speaker

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