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Technical Writing for Medical Products: SOPs, Investigations and Change Records - Webinar

  • ID: 4899880
  • Webinar
  • January 2019
  • Region: Global
  • 120 Minutes
  • Compliance Online
Why Should You Attend:

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 auditors who need to quickly assess whether an unfamiliar organization fulfills requirements. Poor writing therefore can contribute to an audit communication breakdown, leading to undesired audit findings.

This webinar will focus on effective communication of technical information so that an external auditor will quickly understand it and credit your organization with doing the job right.

Areas Covered in the Webinar:

General Technical Writing Guidelines
Guidelines for SOP Writing
Guidelines for Writing Investigation Findings
Guidelines for Writing Change Records
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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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