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

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.

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Last Recorded Date: Mar-2019

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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
Instructor Profile:
Regina Fullin Regina Fullin

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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