Sponsored Webcast: Is Your Labeling an Adverse Event Waiting to Happen? (On-Demand)

1.0 RAC Credits Price: Member: $0 | NonMember: $25
Sponsored Webcast: Is Your Labeling an Adverse Event Waiting to Happen? (On-Demand)
This is a recording from August 2022

Labeling can be an afterthought in the product lifecycle. Compliant labeling is not only regulated but also makes a dramatic difference in patient care. Regulations and standards are constantly changing; (EU MDR, UDI) labeling must do the same. Organizations that fail to prioritize labeling risk lawsuits and outrageous fines or worse, patient injury and death. In this session we’ll explore compliant labeling, examine labeling process gaps, and provide you with the tools to defend a robust labeling process at your organization.

This topic is important to Regulatory professionals as we own the responsibility of creating compliant labeling.

Regulatory labeling compliance will not go away, build a system that accepts inputs and help bring your team to a better understanding of compliance to ensure you can traverse any labeling requirements in your future.

This program will be different from other straight labeling programs as this is taking a wholistic approach to labeling compliance and it’s not just focused on barcodes or symbology. This program will help you to bring up the labeling topic to your leadership to get support for compliance proactively. We will help illustrate why it’s important today and into the future.

Learning Objectives

After this program, participants will be able to:

  • Understand the importance of compliant labeling
  • Have a baseline plan to audit their labeling process; common issues to look for
  • Ability to speak to labeling issues with authority and create buy-in for labeling process changes

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

  • Senior Regulatory Affairs professionals
  • Regulatory Affairs Managers
  • Regulatory Affairs Labeling Managers
  • Regulatory Affairs Associate Directors


Amy Winegarden

Amy Winegarden
Associate Director of Regulatory Affairs, Network Partners Group, Inc.

Amy Winegarden is Associate Director of Regulatory Affairs at Network Partners Group, Inc., a professional services organization serving Life Sciences companies. With over 16 years of medical device industry experience, Amy has supported Respironics, Philips Children's Medical Ventures, Siemens Healthineers, Fisher Scientific, Smith+Nephew, and BD in technical writing, quality, and regulatory capacities.

Amy’s unique experience as first a technical writer and then a regulatory affairs specialist provides perspective into the challenges and symbiotic relationship of labeling and regulatory. Amy has supported products and innovation from research and development through obsolescence as an integral part of the product lifecycle team. She has authored submissions and registered product in the US (FDA), EU (MDD), and global markets and has sound experience in labeling and UDI. She currently takes a deep interest in all things Digital Health enjoying the realm of AI/AR/ML and keeping current on the latest cybersecurity threats.

She is excited to share her learnings and looking forward to the inevitable additional ideas and learnings that will come from robust discussion.


For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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