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WEBINAR - The FDA is Kind of a Big Thing

Registration is Closed

Late Registration may be available until 5:00PM on Oct 7th at the following link:

https://www.eventbrite.com/e/innovation-in-health-the-fda-is-kind-of-a-big-thing-tickets-16909643097

TOPIC: The FDA is Kind of a Big Thing

TOPIC DESCRIPTION: Investors need to do a reality check on what companies say about their regulatory strategy. Michelle and Ti cut through the nonsense.

SPEAKERS: Michelle Lott and Tianna Benson

SPEAKER BIOGRAPHIES:

Michelle Lott and her staff at lean RAQA company have supported 100+ companies with regulatory strategy and submissions, audit preparation and remediation, quality systems compliance, due diligence, and technical support services. Ms. Lott has a very clear way of laying out what the FDA options are and ensuring that companies develop a clear regulatory strategy to meet them. Investors need to know what is doable and how much it will cost to achieve the appropriate regulatory compliance.

Tianna Benson has nearly 10 years of experience in medical device quality assurance and regulatory affairs. She began her career as one of six employees at a medical device startup designing products for the radiologic and ophthalmic spaces. Since then, Ti has developed a proven track record of successful quality management system implementations, quality audits and regulatory submissions for Class II medical devices. She is passionate about improving patient outcomes, and her biomedical and ISO 13485:2016 auditor certifications allow her to help small and midsize companies bring safe and compliant products to market. Ti graduated from the University of Arizona with her B.S. in Biomedical Engineering with an emphasis in biomaterials

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.

When:

Thursday, October 07, 2021, 5:00 PM until 7:00 PM

Where:

Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event

Event Contact(s):

ORCA Admin

Category:

Webinar

Registration is closed

Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.

Please make sure that the following email address is in your Safe Sender list: mailer@mail2.clubexpress.com. System messages like meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance are sent directly from this email address.

You will receive an email 2 days prior to the meeting date with the webinar login instructions or the night prior to the meeting, if registering closer to the meeting 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.

Capacity:

100

Active Member (Regular, Student, Government)

No Fee

Non-Member

No Fee

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