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

Regina Fullin

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In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

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.

Learning Objectives:

  • Learn some quick formatting tips that will make writing immediately more readable.
  • Learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
  • Learn how to format SOPs to facilitate clarity.
  • Learn how to document investigational information in a way that is understandable to non-technical professionals.
  • Learn how to author change records that explain the rationale for change in clear, non-technical language.

Areas Covered in the Webinar:

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

Who Will Benefit:

This webinar is aimed at pharmaceutical and medical device professionals with scientific expertise, who struggle with documenting information so that it is understandable to non-technical professionals.

  • Pharmaceutical and medical device professionals
  • Technicians taking on more authorship duties
  • Document authors
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Regina Fullin,

Regina Fullin is a Senior Compliance / Validation Consultant with Compliance Team, Inc.TM (CTI), where she assists clients in the medical device and pharmaceutical industries to achieve ever-increasing compliance to regulations in the pharma, medical device, and related industries. She has experience assisting with UDI implementations, and has authored several industry articles on the subject of UDI. Regina began her career more than 20 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 projects for companies requiring compliance assistance. Within her role at CTI, Regina also uses her writing skills to publish relevant and meaningful articles to help medical manufacturers stay current with regulatory changes, industry trends and improve product quality. Regina is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. Regina is active in the Northeastern Illinois Section (1212) , and is the Current Chair, having served previously as the Programs Chair. In addition to her Section involvement, Regina also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and annual audit. Regina is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.

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