Overview:
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.
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.
Cost:
Half-day class
Cost: $125 (includes class, all class materials, and snacks)
Instructor Bio: Sheila Ramerman, RAC
Sheila Ramerman is the founder and Principal at SJR Associates, a medical device regulatory affairs, quality systems, and clinical affairs consulting practice located in Eugene, OR. Her consulting practice puts particular emphasis on assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Her clients range from start-up companies who are developing home-testing and near-patient testing devices, to well-established, global medical device manufacturers. Prior to founding SJR Associates, Sheila was responsible for regulatory affairs, quality systems, and/or clinical studies at small or start-up medical device companies in the San Francisco Bay Area, working with a variety of medical device technologies. Sheila has been a moderator and presenter for medical device seminars and webcasts for the Regulatory Affairs Professional Society, and has been a member of RAPS since 1995. She is a guest lecturer in the UC-Santa Cruz Regulatory Affairs Certificate Program, and has been affiliated with OBA’s BioPro WorkForce Training program since early 2007. Sheila began her career as a Medical Laboratory Technician and Clinical Laboratory Scientist in community hospital laboratories, and has worked in the medical device industry since 1989. Sheila holds an AA degree in Clinical Laboratory Technology from Shoreline Community College in Seattle, WA; a BA in Health Services Administration from Saint Mary’s College in Moraga, CA; and she has been Regulatory Affairs Certified since 1998.
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