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Creating Reader-Focused Technical Documents in FDA Regulated Industries

Seminar by  ComplianceOnline
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On-Site / Seminar

Details

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.

Outline

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.

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

Speaker/s

Regina Fullin
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.

Special Offer

For Registration - http://www.complianceonline.com/technical-regulatory-report-writing-for-fda-regulated-industries-seminar-training-80400SEM-prdsm?channel=speedycourse           

 

Note: Use coupon code  NB5SQH8N  and get 10% off on registration.
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At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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