Unlocking the Secrets of an Effective Medical Device Post-Market Surveillance Program: A Deep Dive into FDA Regulatory Requirements, Best Practices and Current Trends
Program Speaker:
Jennifer Mascioli-Tudor
Founder and CEO
JMT Compliance Consulting
Event Agenda:
DATE: Tuesday, 25 June 2024
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 event is being offered virtually. The zoom link will be shared with you via email 1-2 days before the event.
-
Click here to register for this event.
Program Topic:
In today’s rapidly evolving regulatory landscape, staying current on the latest FDA requirements, guidances and technological advancements is more important than ever. Implementing an effective post-market surveillance program for your marketed medical device is crucial for ensuring the ongoing safety, performance, and compliance to regulations in the U.S. market. This webinar will provide a comprehensive overview of FDA regulations governing post-market surveillance requirements, best practices for compliance, and practical strategies for developing and implementing robust surveillance programs. Attendees will gain valuable insights into navigating the complexities of the FDA regulatory landscape, FDA Audit Readiness and leveraging regulatory intelligence and data analysis to enhance and mitigate product and compliance risk. This session will also cover the impact of emerging technologies such as artificial intelligence and big data analytics on post-market surveillance, providing a forward looking perspective on the future of medical device regulation.
Speaker Biography:
With over two decades of dedicated industry experience, Jennifer Mascioli-Tudor has established herself as a seasoned leader in the fields of Quality and Regulatory within the pharmaceutical and medical device industries. Throughout her career, she has successfully led diverse global teams, demonstrating a strong understanding of industry requirements and trends. Her extensive background encompasses a wide range of responsibilities, including strategic quality, regulatory initiatives, regulatory compliance management, and operational excellence practices. Jennifer has a proven track record of implementing robust quality systems, ensuring adherence to stringent regulatory standards, and driving continuous improvement across organizational processes. Jennifer has progressed through several roles of increasing leadership responsibility, working for a range of small, medium, and large strategic organizations in the medical device industry, such as Johnson and Johnson, Medtronic, Boston Scientific and GE Healthcare. She is now Founder and CEO of JMT Compliance Consulting, LLC. (www.jmtcompliance.com) where she is focused on partnering with small, emerging growth Medical Technology companies to drive Business/Quality/Regulatory strategy and Operational excellence initiatives. Jennifer is passionate about building energized, diverse, and inclusive teams who are motivated by a shared mission to transform healthcare. She holds a B.S. in Physiology/Chemistry and French from Eastern Michigan University, an MBA, Global Management from the University of Phoenix and is an ASQ Certified Quality Auditor. Jennifer is an Instructor at UC San Diego, teaching courses to support the Regulatory Affairs for Medical Devices certificate program.
Registration Information:
- Register for the event here
Contact
Pricing – Online – Registration (ends June 24, 2024)
| Registrant Type | Event Price | |
| Member | $10.00 | |
| Lifetime | $10.00 | |
| Non-Member |
$20.00
|
|
|
|
Cancellation Policy
There will be no refunds for cancellations.
Recent Comments