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Creating Reader-Focused Technical Documents in FDA Regulated Industries  

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Document Control Specialists, Software Specialists, Quality/R&D Technicians, Quality/Production Supervisors, Technical Specialists, Quality/Technical Investigators, Compliance Professionals, Manufacturing/Production/Design Engineers, Process Owners

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Seminar Summary:

Advanced technology may have pushed effective communication to the wayside to make clear writing a lost art, now due for revival! In the Information Age, a surplus of technical data proliferates with very little information communicated in plain language. (see full course description)

 

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Training Course Syllabus:


Creating Reader-Focused Technical Documents in FDA Regulated Industries

Course Description:

Advanced technology may have pushed effective communication to the wayside to make clear writing a lost art, now due for revival! In the Information Age, a surplus of technical data proliferates with very little information communicated in plain language. Unclear communication can confuse compliance your reader, who needs to use the information to make critical decisions in a manufacturing environment for products that have life-and-death consequences. Poor writing can therefore not only contribute to poor communication, but to human survival.

This seminar will focus on effective communication in technical documents. While true that effective communication is essential for auditors to assess your regulatory compliance, it is more important that clear documentation can improve the safety of the products you work hard to produce. Rather than focusing on what information to include in technical writings, focus on your reader, who must understand the intended message.

In this two-day workshop, you will learn how to structure a technical document with the reader in mind. You will learn how to paint a mental picture of the content, to enhance reader understanding. Participants should bring an in-process technical report to the workshop, to immediately yield business outcomes.

Learning Objectives:

The workshop objectives are to help technical writers:

Plan and write consistent, reader-focused reports and other technical documents.
Write in a style that is clear and concise.
Develop content with a bottom-line message at the top, and main points that stand out and are reinforced with appropriate data.
Use Professional Touch tools that help build working relationships with readers.
Develop writing that groups content into digestible chunks to improve reading comprehension.
Work on a technical writing piece brought from the workplace to immediately apply the skills.

Course Outline:

Day One (8:30 AM – 5:00 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

9:00 – 9:45 am: Orientation with writers seated in teams
The workshop begins with two team exercises to build reader awareness
Discuss strategies and criteria for more reader-focused reports
9:45 – 10:30 am: Reader-Focused Structure and Content
Discussion of FDA 483s, and how they relate to technical writing – Why effective Technical Writing is essential to compliance
How to create a Report Template that suits the purpose of your document.
10:30 am - 11:00 am: Break
11:00 am - 12:00 pm:
Discuss steps to Planning your Report
Discuss various Types of Documents in FDA-regulated industry: SOP, Investigation Report, Change Record, Validation Protocols/Reports
How to write an impactful Purpose Statement
How Generate Appropriate Content
12:00 pm – 12:45 pm: Lunch
12:45 pm – 2:45 pm: The Drive Toward Clarity
How to use mental pictures to communicate with clarity
How to identify primary information so it can be placed in the primary position of the document.
2:45 pm – 3:00 pm: Break
3:00 pm – 4:30 pm: Putting It All Together
Perform a Self-assessment to determine progress
Introduce a Clarity Calculator for assessing the clarity of written communications

Day Two (8:30 AM – 4:30 PM)


8:30 am – 10:00 AM: Quality Control of Documents
Review of Day 1
Aha! Exercise to help participants view their documents from a different perspective.
Making and Supporting Main Points
How to use a Label sentence to identify the Main Point
How to identify related information so it can be chunked together
How to build an impactful paragraph that is clear to anyone
10:30 am – 10:45 am: Break
10:45 am – 12:00 pm: Flow for Better Comprehension
What are Linking Words, and how they aid reading comprehension
Self-Assessment to determine areas to improve upon before conclusion of the workshop
12:00 pm – 12:45 pm: Lunch
12:45 pm – 2:00 pm: Professional Touch
How to write in the Reader’s (and Regulator’s) language, without using unnecessary jargon
Tips being specific without being wordy
How to meet the FDA’s “Adequacy” criteria to prevent 483’s and Warning Letters
Discuss the Importance of Tone, as a way of preventing misunderstanding of your document.
How to review with an eye on formatting for Understanding
2:00 pm – 4:25 pm:
Use this time to Practice on Your Own Report. If necessary, some of this time can be a break
Evaluate Your Draft: Compare your finished product with the working draft your brought to the workshop, identify future areas for focus
4:25 pm– 4:30 pm:
Workshop Summary and Evaluation

Seminar Summary:

Advanced technology may have pushed effective communication to the wayside to make clear writing a lost art, now due for revival! In the Information Age, a surplus of technical data proliferates with very little information communicated in plain language. (see full course description)

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