Fundamentals of Electronic Medical Device Reports (eMDRs) to FDA

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Event Agenda

DATE: Wednesday, 19 July 2023

TIME*: 5:30 – 6:00 PM Light Dinner and Networking (In-Person)

6:00 – 6:05 PM Welcome and Announcements (In-Person and Virtual)

6:05 – 7:30 PM Program Presentation (In-Person and Virtual)

7:30 – 8:00 PM Q&A (In-Person and Virtual)

* Times are in Pacific Daylight Time (PDT)

LOCATION: This event is being offered both IN PERSON and VIRTUALLY. When you register, you will be able to choose how you will attend the event.

If you register to attend IN PERSON, please join us at:

Neurocrine Biosciences, Inc.

12790 El Camino Real

San Diego, CA 92130

- - - - Click here to register for this event (IN-PERSON attendance option)

If you register to attend VIRTUALLY, you will receive the Zoom link 1-2 days before the event.

- - - - Click here to register for this event (VIRTUAL attendance option)

Program Details

Fundamentals of Electronic Medical Device Reports (eMDRs) to FDA

Learn the who, what, when, where and why of preparing and submitting electronic medical device reports (eMDRs) to FDA.

Speaker Biography:

Erica Livingston received a B.S. in Biology from University of California, San Diego in 2002. She worked at the bench in assay and product development at Salk Institute for Biological Studies, Johnson & Johnson Pharmaceutical Research, Hologic and several start-ups, before transitioning into quality system management. Erica has been in Quality Assurance (QA) since 2008 and specializes in quality system development, implementation, and maintenance.

Erica earned the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society. Erica holds certificates in ISO 14971 Risk Management, MDSAP, verification and validation and Lead Auditor for ISO 13485:2016. In addition to extensive experience with ISO and FDA medical device requirements, Erica has experience with LDTs, CLIA/CAP accreditation, tissue banking standards and clinical laboratory requirements.

Erica started in commercial assays and diagnostics and has developed into a collaborative leader of development and production of electromechanical devices, injection molded parts and devices, catheters, hand tools, assay readers, and combination products.

Erica brings a deep understanding of operations and the burden a quality system can place on a company if it is not implemented correctly. Her experience with operations allows her to define processes that work. She brings her vision of ensuring the quality system adds value to the organization while maintaining regulatory compliance.

Registration Information:

Click here to register for this event (IN-PERSON attendance option)

Click here to register for this event (VIRTUAL attendance option)

Contact

[email protected]

Pricing Registration

Registrant Type	In-Person price (Registration ends Sunday, 16 July 2023)	Virtual price (Registration ends Tuesday, 18 July 2023)
Member	$25	$10
Lifetime	$25	$10
Non-member	$35	$15

Cancellation Policy

There will be no refunds for cancellations.