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60 Min Virtual Webinar Enhancing Healthcare Efficacy: The Critical Role of High-Quality Medical Device QMS and UDI Data
By Compliance SpotlightFollow
When and where
Date and time
Friday, September 8 · 10 – 11am PDT
Location
Online
Refund Policy
Contact the organizer to request a refund.
About this event
- 1 hour
- Mobile eTicket
Are companies ready when product data is requested? Is the current version stored in an excel workbook — a hard copy in a filing cabinet or residing on a PC with a team member? When data is needed, the integrity and curation process become important. Just storing product data is not enough. It is time to leverage medical device QMS (Quality Management Systems) and improve product data quality.
During product development, strategic Product Lifecycle Management/Quality processes along with systematic centralization can make or break compliance milestones and post-market activities. In addition, the Unique Device Identification (UDI) data submitted to global health authorities forms a key component in communicating product data to downstream users.
To reach a competitive edge, companies with the best ‘data hygiene’ are prepared when patient or compliance issues arise. Identifying what is required for a portfolio can be difficult, but it is important to get it right. Supply chain, healthcare providers and patients depend on accurate product data.
In this webinar, industry veterans will discuss questions around ‘lessons learned’ from their work in providing solutions for data quality and related concepts.
The speakers will share key lessons learned on the importance of adopting a strategy for ‘quality’. These include product workflow processes and UDI implementations that will help shape US and global UDI approach:
- What is the impact of the US Food and Drug Administration (FDA) Quality System Regulation (QSR) transition to ISO 13485?
- What role does UDI data play in the QMS?
- Collaborative events in the supply chain and product data importance
- Building quality into the product workflow — reducing cost, improving time to market
- Planning UDI and quality strategy for the US (and global) market
- Where to get guidance
Who Should Attend:
- Regulatory Affairs/Operation Leaders
- Product Managers and Business Analysts
- Manufacturing, Operations and Supply Chain Leaders
- Quality Leaders
- IT Support
What You Will Learn:
This webinar will be a helpful walk-through of the main takeaways in the published information from the US Food and Drug Administration (FDA) and experienced guidance from the Unique Device Identification (UDI) ‘go-to’ specialists. It is for regulatory teams working on the 2022 US FDA Class I UDI compliance and/or EU EUDAMED (European database on medical devices) and health authorities.
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