Technical Writing & Documentation within the FDA Regulated Environment - Half-day Class
Good technical writing is clear and concise, and can even be interesting! But too many technical employees don’t know the principles of good technical writing. General concepts of technical writing will be presented, and specific examples pertinent to medical industries will be used. Examples include lab notebooks, specifications, policies/procedures, batch records, device history records, study protocols and reports, and other quality system documentation. “Good documentation practices” will also be discussed.
Instructional methods include: Lecture format, with questions/answers/discussion throughout. Templates for each type of document are provided to class attendees and discussed, as the document type is covered in this 4-hour class.
How You Will Benefit:
By the end of the course, participants will gain the following:
- Learn the basic concepts of technical (and any business) writing;
- Learn how to apply these concepts to their job responsibilities and the documents they use;
- Receive examples of each of the major types of technical documents typically used in an FDA-regulated company
Course Outline:
1) Technical Writing Basics & General Concepts
- What is technical writing and where is it found?
- Language consideration (grammar & tense/tone; jargon &acronyms; symbols & abbreviations; sentence length & complexity)
- Document Organization & Writing Styles
- Style Guidelines
- References
2) Specific Examples of Technical Writing in the FDA Regulated Environment
- Quality System documentation hierarchy
- Quality System documentation through the product life cycle (lab notebooks, product specifications, policies/procedures/work instructions, test plans & reports, device master records, batch/lot records, device history records, regulatory submissions, user manuals/instructions for use, marketing materials)
- Good documentation practices
- References
Who Should Attend:
Anyone who is responsible for writing and/or maintaining technical documents. This includes engineering, laboratory, manufacturing, QA/RA, and documentation services employees especially. This course will also be of value for anyone who writes reports or procedures; the basic concepts can be applied to any kind of business writing.