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ASQ: Split Personalities of QMS under FDA QSR, ISO 13485 and MDSAP

March 30 @ 6:30 pm - 7:30 pm

ASQ Montreal — Split personalities of QMS under FDA QSR, ISO 13485 and MDSAP (Medical devices industry) (2022-03-30) 3809
ASQ Montreal — Split personalities of QMS under FDA QSR, ISO 13485 and MDSAP (Medical devices industry) (2022-03-30)
Photo by Piron Guillaume on Unsplash
(Webinar in English | Webinaire en anglais)
(Bilingual Q&A Bilingue)

30 March 2022 19:00

Networking Opportunity 18:30

Michelle Lott

Trying to maintain compliance under FDA QSR, ISO 13485, and MDSAP can leave a company with a QMS identity crisis.

This webinar will discuss strategies to manage regulations, risks, and audits in the medical device industry for the US & Canada. Specifically, we will explore differences in ISO 13485, FDA, and MDSAP audits and the impact on audit management and the structure of the quality management system.

About our speaker: Michelle Lott, is a principal and founder of leanRAQ. She has 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.

Join-us !

Date & Time: Wednesday March 30th, 2022 5:30pm CDT
End Date & Time: Wednesday March 30th, 2022 8:00pm CDT
Venue: Webinar
Categories: Meeting, Webinar, Social Event
Host Type: Geographic, Technical

Details

Date:
March 30
Time:
6:30 pm - 7:30 pm
Event Category:
https://my.asq.org/communities/events/item/138/60/3809

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