US Regulatory Essentials, Devices (November 2021)

When:  Nov 18, 2021 from 10:00 to 16:00 (ET)

Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the U.S. in this intensive, two-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 post-market, as well as compliance and enforcement requirements. The speakers will also cover FDA guidance, and options and strategies for FDA submissions.

 

Pricing Amounts & Deadlines

10 November 2020 – 4 April 2021: Early Bird $800.00 Member | $900.00 Nonmember

5 April – 28 April 2021: Regular $900.00 Member | $1000.00 Nonmember

 

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.

Agenda

Workshop Overview

  • FDA history
  • FDA organization
  • DICE role

Overview of Medical Devices and IVDS
  • Classification
  • 513(g) and de novo
  • PMA perspectives
  • 510(k) perspectives
  • IDE and HDE perspectives
  • Clinical conduct perspectives        

QSR/QMS and Design Control

Breakout Rooms
  • Medical device
  • IVD Breakout
Postmarket Compliance is No Easy Journey
  • Complaint handling and management
  • Understanding medical device reporting
  • Corrections/Removals (recalls)
Navigating an FDA Inspection and Aftermath
  • The knock on the door
  • Conduction inspection
  • Close-out meeting
  • Post-inspection and enforcement
Advertising, Promotion and Labeling
  • Label and labeling
  • Claims substantiation
  • Lessons learned from warning letters
  • Disseminating information about unapproved devices
  • Intended vs. off-label use
  • Direct-to-consumer advertising
  • Social media

Speaker

David Chadwick, Director, Regulatory Affairs / Regulatory Science, Cook Medical
David Chadwick, PhD, RAC has over 25 years of experience in the medical device industry in such areas as basic research and development, clinical research, and for the past 20 years, regulatory affairs/quality assurance. The scope of his experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, ENT devices, drug delivery, electrosurgery, cardiovascular stents and catheters, with many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. My primary focus resides in medical devices and combination products, but my experience also expands into drug regulation and submission.  He currently serves as the director of regulatory science for Cook Medical, providing high-level regulatory and clinical advice on pre- and post-market safety, quality, performance, testing, compliance, and marketing issues pertaining to medical devices globally.

Christie Hughes
Consultant
Qserve Group US. Inc

Christie has over 25 years of experience in the in vitro diagnostic medical device (IVD) industry. With a degree in clinical laboratory science, she began her career in hospital clinical laboratories. Upon moving into industry, Christie worked in various quality and compliance roles at small and startup companies where she established their quality management systems (QMS) compliant with ISO 9001, ISO 13485, and FDA QSR requirements. To learn other aspects of the industry, Christie led commercial and post-launch phases for a molecular test as a Product Manager before moving into Regulatory Affairs where she developed and executed domestic and international regulatory strategies for IVD instruments, software, and multiplexed assays (protein and molecular). After many years in various roles in industry and earning her master’s in public health degree in epidemiology, Christie moved into consulting where she continues to leverage her experience and knowledge to determine elegant solutions for clients’ QMS and regulatory affairs challenges.

Wade Schroeder
Greenlight Guru

Wade Schroeder is a medical device quality consultant who loves working with product development and QA/RA teams to help implement and execute their QMS. He has spent most of his career as an engineer in new product development setting up processes and leading teams as an energetic unit that can be relied upon for meeting deadlines, working together, and enjoying work. Wade works with about 50 medical device startups at Greenlight helping them get their QMS started, guides them through product development in compliance with FDA and international regulations, and advises them through regulatory submissions to get their product to market.


Mark DuVal, DuVal & Associates, P.A.
Mark DuVal, J.D., is president and CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His firm provides strategic regulatory advice; handles product pre-submissions as well as filing, negotiating and appealing 510(k)s, de novos, PMAs and the like; works on compliance and enforcement matters; develops compliance programs; designs and implements sophisticated marketing programs; counsels on reimbursement matters; conducts sales training and interfaces extensively on behalf of companies with the FDA with relation to clinical trial negotiations, enforcement negotiations; policy arguments, appeals of all kinds (LB Flag, 21 CFR 10.75, 517A, etc.) and so on. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, the Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs and Services Program at St. Cloud State University.  He is a frequent contributing speaker/panelist to MMDA, Minnesota Medical Alley, RAPS national and the RAPS Minnesota Chapter and is on the programming committee of the Medtech Investing Conference in Minneapolis.


Etienne Nichols, Greenlight Guru
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in a paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Tony Blank
CoFounder & Senior Advisor
Barton & Blank, LLC

Andrea Gadsby
Director of Quality Assurance
Cook Incorporated

Larry Pool
Medical Device Guru
Greenlight Guru

Event Policies

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 raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

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. 

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org