Standards solve problems. They are universally valued as important and valuable tools to support the design, manufacture, testing, and regulation of medical devices and, as such, play a key role in promoting safety and public health. When manufacturers rely upon FDA-recognized standards, submission documentation is less burdensome and more streamlined. This session will demonstrate the value of standards, explain how to cite them to maximize efficiencies, including in eSTAR, and introduce participants to the FDA’s latest program to enhance standards’ use: the Accreditation Scheme for Conformity Assessment, or ASCA. This discussion will also provide updates and insights to help regulatory professionals understand the FDA eSTAR program and how to cite standards using the eSTAR templates.
Registration Fees & Deadlines
Member $10 | Nonmember $20 | Student:$0
Agenda
Introduction: 5 min
FDA presentation: 30 min
FDA Q&A: 25 min
Chapter Networking: 60 min
Speakers
Jennifer Coble
Regulatory Policy Analyst, FDA
Jennifer Coble came to the FDA after a 25+ year career in the clinical laboratory and pharmaceutical spaces. Over her career, she held various roles around Quality Management Systems and adherence to regulatory standards. This expertise has run the gamut from managing laboratory audit programs to vendor audit oversight and regulatory audit readiness. Additionally, Jennifer served as liaison between multiple business units and regulatory teams with the goal of educating the business around why we need to comply with adherence to standards. She culminated this experience with regulatory compliance responsibility for her organization's proprietary software medical devices across US and EU authorities. Jennifer holds an AAS in Laboratory Technology, a BS in Computer Information Systems and a Master of Project Management. Currently, Jennifer supports the Accreditation Scheme for Conformity Assessment (ASCA) program within CDRH.
Sponsors
Barnes & Thornburg LLP
Providing facility, food and beverages for this event
Location
Barnes & Thornburg LLP,
11 S Meridian Street
Indianapolis, IN 46204
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org