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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
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HomeCurrent/Future EventsWebinar - Successful FDA Submissions: What Clinicians and RA Professionals Need From Each Other

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Webinar - Successful FDA Submissions: What Clinicians and RA Professionals Need From Each Other

When:
Thursday, November 12, 2020, 8:00 AM until 10:00 AM
Where:
Webinar - link will be emailed to attendees 2 days prior to the meeting.

Additional Info:
Event Contact(s):
ORCA Admin
Category:
Webinar
Registration is closed
Payment In Full In Advance Only
RSVP by Wednesday, November 11, 2020

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 after payment is processed 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
No Fee
$60.00

The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
This webinar will be recorded.

NEW START TIME is 8:00 AM PST


TOPIC: Submitting to the FDA requires multiple information inputs. This talk will discuss how the information is pulled together to ensure a successful submission. 

TOPIC DESCRIPTION: Regulatory Submissions

SPEAKER: Michelle Lott

SPEAKER BIOGRAPHY: Michelle Lott is founder and principal of learnRAQA. She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling(!), because dealing with regulators can be emotionally draining. Her clients delegate those things to her, so they can focus on winning in the marketplace. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP), holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.

WHO: Clinical, regulatory, quality, manufacturing and legal

Attendance at this meeting may be applied as 1.5 points towards RAC re-certification