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

Duration: 60 Minutes
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.
Technical Writing Guidelines
Instructor: Regina Fullin
Product ID: 501724
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.

Objectives of the Presentation
  • 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
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.

Areas Covered
  • General Technical Writing guidelines
  • Tips to improve readability and understanding of your documents
  • Guidelines for SOP Writing
  • Guidelines for writing Investigation Findings
  • Guidelines for writing Change Records
  • Proofreading your work
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
  • Investigators
  • Subject-Matter Experts wishing to share their knowledge
Topic Background
Regulators have a number of expectations when they come to inspect a facility that manufactures medical products. They expect that policies and procedures are available, and understood by everyone who uses them. They expect that all equipment, policies, and procedures be in a state of control, and that changes to these are managed through a well-defined change control system. They expect that the records for these changes be accessible and scientifically justified. Furthermore, in the event of any unexpected occurrences, regulators expect that there be a well-defined investigation process that clearly identifies the root cause, how the root cause was identified, and any supporting data. All of these can be a challenge to technical professionals who understand the technical aspects of their jobs, without the background necessary to document their knowledge in a clear, concise way so outside regulators understand it. This webinar introduces the technical professional to some tips and tricks to simplify the documentation aspects of their jobs.
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Live Session - How it works
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Regina Fullin is the Director of Compliance Consulting Services at Compliance Team, Inc. (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 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) as Past 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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