Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the United States in this intensive, one-day online workshop.
Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating devices and IVD products. They will review advertising, labeling and promotion postmarket, as well as compliance and enforcement requirements. The speakers will also cover US Food and Drug Administration (FDA) guidance as well as options and strategies for FDA submissions.
Registration Fees & Deadlines
Present - 18 November 2024: Member $585 | Nonmember $695
19 November 2024 - 18 December 2024 Member $700 | Nonmember $825
Who Should Attend?
This workshop will benefit individuals who are new to the regulatory profession, entering the medical device industry, or changing companies and/or product lines or industry. The material will also be helpful to anyone studying for the RAC-Devices exam.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
| Time | Topic | Facilitator |
| 8:00 - 8:50am EST | FDA Breakdown & QMSR Overview | Vincent Cafiso
|
| 9:00 - 9:50am EST | Audits & Inspections | Sara Adams |
| 10:00 - 10:50am EST | Design Controls | Etienne Nichols |
| 11:00 -1150am EST | Medical Device Classifications & Submissions | Vernon Baker |
| 11:50am - 1:00pm EST | BREAK | |
| 1:00 -1:50pm EST | Specifics of IVDs & LDTs | Christie Hughes |
| 2:00-2:50pm EST | Clinical Investigations | Chris Rush |
| 3:00-4:30pm EST | Labeling & Ad Promo | Mark Duval |
Speakers
Etienne Nichols
Head of Industry Insights & Education, Greenlight Guru
Sara Adams
Senior Medical Device Guru, Greenlight Guru
Chris Rush
Solutions Enginner II, Greenlight Guru
Christie Hughes
Principal Consultant, Qserve Group
Mark DuVal
President, DuVal & Associates, PA
Vincent Cafiso
Director, Quality and Regulatory Services, CREO
Veron Baker
Senior Medical Device Guru, Greenlight Guru
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