18 August 2016
5:00–7:00 pm
GE Healthcare Research Park
Wauwatosa, WI
The FDA regulation established a single device identification system that is consistent, unambiguous, standardized and hopefully globally harmonized. All manufacturers of Class II medical devices will be required to comply with the new UDI methodology by 24 September 2016. This session is specifically structured for Class II medical devices facing imminent compliance dates as well as health providers and hospitals moving to understand UDI so that they can incorporate it in their existing systems. Time is ticking and the dealine is around the corner. Join us to get your last minute questions answered before it is too late.
You will learn best from those that “have been there done that.” Tracey Holevas will share her own internal stories on the technical challenges GE Healthcare encountered, the data submission experience to the GUDID, the necessary internal company coordination and how you can create your own strategic implementation plan.
Topics to be covered include:
- UDI implementation strategies
- How to create a UDI compliance plan for your organization
- How UDI can improve business processes
A light meal will be provided for all meeting participants and attendees may claim two recertification points.
Date/Time:
Thursday, 18 August 2016
5:00–5:30 pm Registration, Check-In
5:30–6:00 pm Networking and Dinner
6:00–7:00 pm Speaker Presentation and Q&A Session
Location:
GE Healthcare Research Park
9900 W. Innovation Drive
Wauwatosa, WI 53226
Get directions online or call +1 800 437 1171
Registration:
Advance Registration (prior to 12 August):
RAPS Members: $30 Nonmembers: $40
Registration (on or after 12 August):
RAPS Members: $40 Nonmembers: $50
Speaker:
Tracey Holevas, quality and regulatory executive, program management UDI, GE Healthcare
Holevas has held various roles within the quality-regulatory organization of medical device manufacturing including quality assurance, quality deployment and regulatory compliance for the past 20 years. She is currently building a new transactional process within the global quality and regulatory organization in GE Healthcare to ensure compliance to the global UDI regulations. This process involves activities from new product development through commercial offerings and postmarket surveillance.
Holevas chairs the UDI Task Force for MITA and is a member of various GS1 working groups refining the requirements for applicability to the healthcare industry.
Local Contact:
Elizabeth Mathew, RAC, RAPS Wisconsin Chapter
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations