ComplianceOnline

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

Instructor: Regina Fullin
Product ID: 704304
  • 27
  • January 2017
    Friday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 120 Min

Live Online Training
January 27, Friday 10:00 AM PST | 01:00 PM EST
Duration: 120 Min

$229.00
One Dial-in One Attendee
$499.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$379.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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
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.

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