ComplianceOnline

4-Hour Virtual Training: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Instructor: Joy McElroy
Product ID: 704531
  • Duration: 4 hrs

recorded version

$499.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$599.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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:

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. She then moved into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering.

Now with 14 years’ experience as a consultant, and 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, auditing, and GMP and GLP training. She has written and executed equipment qualification and validation protocols for numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Ms. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, Good Documentation Practices, and GMP and GLP training.

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