How to Document Quality Investigations to Meet FDA Expectations - Webinar

  • ID: 3734859
  • Webinar
  • 60 Minutes
  • Pathwise
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Your investigation reports have valuable information to share, but are not effective if your audience doesn’t understand them. Since 2010 with the signing of the Plain Writing Act, the FDA has committed to using plain language. In the FDA’s own words, ”Writing in plain language is not unprofessional. It’s not “dumbing down” the message or “talking down” to the audience. When you write clearly and get to the point without using unnecessary words or technical jargon, you get your message across more quickly and increase the chance the information will be understood and used.” This webinar will teach the writing skills necessary for compliant, effective, and efficient quality system management. After attending this webinar, you will be able to understand what plain language is, how to write it, and what the FDA and world regulatory bodies expect when it comes to documenting quality investigations.

Attendees learn proven technical writing techniques that meet regulatory expectations, including:

- Keys to a readable writing style
- Clear and concise writing
- Document Design

With particular focus on:

- Proper audience identification
- Concepts for a clear and concise writing technique
- Tools for designing documents to focus on the reader
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Cristy Draper
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