Program Speaker:
Michelle Lott, RAC
Event Agenda
DATE: Wednesday, 17 May 2023
TIME: 6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION: This is an ONLINE event on zoom virtual platform
Register here
Program Details
Risk Management according to ISO 13485 – impacts of QMSR and TR 24971
In this presentation, we will discuss:
- The proposed Quality Management System Regulation proposed final rule from the FDA which includes the adoption of many long standing risk management principles from ISO 13485 and ISO 14971 and how this could affect documentation in premarket submission and post-market inspection activities.
- Perspectives from TR 24971 affecting the application of ISO 14971 (for instance, should you or shouldn’t you use P1 X P2?)
- BYOI (Bring Your Own Issues) – come prepared with your own recent FDA and CE submission and audit experiences that challenged your processes or documentation for a round table discussion. Or issues your own teams disagree over regarding the application of risk management.
This is intended to be an interactive discussion to learn together from each other’s experiences and find alternative approaches.
Speaker Biography
Michelle Lott is founder and principal of leanRAQA. 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.
Registration Information:
Register here
Contact
Pricing – Online – Registration (April 28, 2023 – May 16, 2023)
| Registrant Type | Price |
| Member | $10.00 |
| Lifetime | $10.00 |
| Non-Member |
$15.00
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Cancellation Policy
There will be no refunds for cancellations.
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