Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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WEBINAR - Impacts of Clinical Laboratory Improvement Amendments
Thursday, October 28, 2021, 8:00 AM until 10:00 AM
Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event
Registration is required
Payment In Full In Advance Only
RSVP by 6:00PM Wednesday, October 27, 2021
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TOPIC: Impacts of Clinical Laboratory Improvement Amendments
TOPIC DESCRIPTION: The Clinical Laboratory Improvement Amendments are amendments to the Public Health Act established in 1988 to establish quality standards for laboratory testing performed on human specimens for the purposes of diagnosis, prevention, or treatment of any disease or assessment of the health of a human. In her presentation, Katrina Rogers will describe the CLIA program, how the CLIA and FDA in vitro test regulations work together, and what that means for sponsors of new laboratory diagnostic tests.
SPEAKER: Katrina Rogers
SPEAKER BIOGRAPHY: Katrina Rogers is a leadership expert with over 25 years of experience discovering, developing, and manufacturing medicines and related technology. An expert in laboratory and technical operations, she is also an ASQ Certified Manager of Quality/Organizational Excellence and Pharmaceutical GMP Professional. Her professional services firm, Katrina Rogers Consulting LLC, specializes in dramatically decreasing the cost and time of bringing new medical products to market.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification
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.