Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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WEBINAR - Move Beyond Compliance - Culture of Quality
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Location
Webinar - Link will be emailed to attendees on the day of the event. USA
Registration Info
Registration is required before Friday, November 14, 2025 at 11:30 AM
Payment In Full In Advance Only
Registration closes 30 minutes before meeting start time.
Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.
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You will receive an email confirmation of your completed registration followed immediately by a separate email with the subject "Event Videoconference Notification." The Zoom link, Meeting ID, and Passcode for this webinar meeting will be in the second email on the event date. If you don't receive the instructions within this time frame, please contact us at info@orcanw.org as soon as possible.
PAID FEES ARE NON REFUNDABLE.
For webinar events, payment is REQUIRED at the time of registration.
About this event
TOPIC: Discover the Voluntary Improvement Program (VIP) supported by the FDA
TOPIC DESCRIPTION: The Voluntary Improvement Program (VIP) is the first Case for Quality (CfQ) initiative recognized by the US Food and Drug Administration (FDA) with Final Guidance "Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program." The program brings together the FDA, the Medical Device Innovation Consortium (MDIC), ISACA and the medical device industry to work together to enhance device quality and patient safety. VIP leverages a tailored version of the Capability Maturity Model Integration (CMMI) framework, created specifically for the medical device industry, with FDA Regulatory Opportunities to accelerate improvements to device manufacturing and quality
SPEAKER: Timothy Lee
SPEAKER BIOGRAPHY: Timothy Lee is the Strategic Account Executive of Global Sales of ISACA who is responsible for all the deliverables of the VIP appraisal. He started his career with British Standards Institute (BSI) and helped countless of companies meet their compliance goals of ISO 13485, MDSAP, and CE Marking certification for almost a decade. Graduated from the University of WA in Seattle with a degree in Political Economy, a minor in business/sales and was also part of a pharmacology research lab.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification/ continuing education from the following organizations:
1.5 pts |
RAC recertification from RAPS |
1.5 CEUs |
CCRP recertification from SOCRA |
1.5 CEUs |
CIP recertification from PRIM&R |
All attendees must be registered. Access to education content is a benefit of membership or guest attendance. The link to the webinar is intended for the registered person ONLY and any access/distribution of materials beyond the individual registrant is strictly prohibited. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
This webinar will be recorded.
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