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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
After this program, participants will be able to:
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.
Amy WinegardenAssociate 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.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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