Creating Reader-Focused Technical Documents in FDA Regulated Industries: 2-Day In-person Seminar
Regina Fullin, ASQ-Certified Manager, (CMQ-OE), Validation Consultant, Compliance Team, Inc.
Research Triangle, NC
| Monday, December 5, 2016 | Tuesday, December 6, 2016
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.
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.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
Who Will Benefit:
Anyone working in regulated environments for pharmaceuticals, medical devices, foods or dietary supplements can improve technical writing skills. Affected job titles range from entry-level employees to managers, and include individuals with the following job titles:
- 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
- Quality Engineers/Auditors
|Day One (8:30 AM – 5:00 PM)
||Day Two (8:30 AM – 4:30 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
- 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
Meet Your Instructor
ASQ-Certified Manager, (CMQ-OE), Validation Consultant, Compliance Team, Inc.
Regina Fullin is a compliance consultant with Compliance Team, Inc.TM (CTI), where she assists clients in the medical device and pharmaceutical industries to help them achieve ever-increasing compliance to regulations in the pharma, medical device, and related industries. She began her career more than twenty years ago in a quality role at Abbott Laboratories, and has worked in quality roles at other companies, including GE Healthcare. Her particular areas of expertise focus on validation, equipment qualification, complaint handling, technical writing and remediation for companies requiring compliance assistance. Within her role at CTI, Ms. Fullin also uses her writing skills to publish meaningful articles to help medical manufacturers stay abreast of industry trends and improve product quality.
Ms. Fullin believes that quality is not only an ethic, but essential to optimal business performance. To this end, she is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. She is active in the Northeastern Illinois Section (1212) as Programs Chair and is Chair Elect. In addition to her section involvement, she also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and participates in the annual audit. Ms. Fullin also holds certifications as a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.
She holds a Bachelor’s Degree in the Teaching of Biology from the University of Illinois at Urbana-Champaign. She has used this teaching degree to teach like-minded professionals the skills needed to survive and thrive in an FDA-regulated environment.
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Research Triangle, NC (Venue to be announced shortly)
December 5-6, 2016
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