In order to provide you a level of certainty in planning in
the face of the COVID-19 situation, this event is now being delivered online as
an online workshop. We are working with our instructors to ensure
that the same learning objectives and quality of the education will be
delivered regardless of this modification. RAPS is closely monitoring
developments in the Coronavirus (COVID-19) outbreak. See our public safety page for
the latest updates.
Uncovering
and Managing Successful Post Market Compliance for Medical Devices: Complaint
Handling, Medical Device Reporting, and Recalls
Customer
satisfaction plays a significant role in measuring a product’s post market
performance. It is an indicator of how effective the product performance is
managed. Both the quality system regulation (QSR) and the International
Organization for Standardization (ISO) require procedures and processes to
monitor and control your post market problems. The complaint-handling mechanism
not only collects feedback from unsatisfied customers, but also provides means
for failure investigations and subsequent corrective and preventive actions
(CAPA). Recall compliance involve regulatory obligations as well as proper and
timely reporting. Failure to properly
report events and take corrective and removal actions can cause costly problems
for a manufacturer and can be life threating for consumers. The number of
device companies having their recall classified as a Class I has surged in the
past three years. During this training, we will address all aspect of the
recall process. This course will provide an understanding of MDR compliance and
the interrelationship of complaint handling, CAPA, and risk management
processes. Workshop attendees should expect to come away from this course with
a practical framework for understanding recall compliance and the
interrelationship from Part I on complaint handling and risk management
processes. It will be beneficial to all device manufacturers and is recommended
for any individuals or teams that are involved in post marketing of medical
devices.
Registration Closes: 11 August 2020
Refund Deadline: 13 July 2020
RAC Credits: 12 (Upon attending and
completing the program)
Will the meeting be recorded? No
Registration to 13 July 2020
RAPS Members: $800
Nonmembers: $900
Registration from 14 July to 11 August
RAPS Members: $900
Nonmembers: $1000
NOTE: Advance registration
is required for this workshop therefore participants are encouraged to register
early. Onsite registrations are not accepted.
Program Schedule
Wednesday, 12 August (9:00am–5:00pm)
Topics will include (but not limited
to):
·
Complaint handling and
FDA expectations
·
Medical device reporting
(MDR) procedures -- regulations, procedures, and malfunctions
·
MDR reporting by firm, agents, and
voluntary malfunction summary reporting (VMRS) and eMDR discussion
·
Guidance
documents update
·
Being
recall ready
Thursday, 13 August (9:00am-5:00pm)
·
Recalls, Definition and Legal Authority Overview
·
Corrective and Preventative Actions (CAPA)
·
Health Hazard Evaluations HHE/HRA
·
Elements of a Correction and Removal -- 806
Reporting
·
Developing Effective Strategies / Communicating and Negotiating
with FDA (45mins)
NOTE: The
agenda may vary based on changing requirements.
Faculty
Rita Hoffman, principal
consultant
Cancellation or Substitutions
RAPS reserves the right to cancel this program at its sole
discretion.
All cancellation requests must be submitted in writing to raps@raps.org. RAPS
is unable to accept cancellations by phone. Please specify the name of the
person registered and event title.
Due to uncertainty surrounding the COVID-19 situation’s impact on travel our
standard cancellation fees will be waived. Should you need to cancel your
registration, you can apply your credit to any RAPS program for the next 12
months.
Substitutions may be accepted with written approval from RAPS and must be
submitted to raps@raps.org.
Due to uncertainty surrounding the COVID-19 situation, RAPS will allow
substitutions up to the first day of the event.
Proof of Attendance
RAPS will send an electronic letter or a
certificate of attendance upon request.
Questions
Call RAPS Solutions Center at +1 301.770.2920,
Ext 200
Other Information
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.
Registration Form
If it is your preference, please use the
Registration Form to register by mail, email or fax. To expedite your
registration for mail orders, your employer must include a copy of the
completed registration form. A RAPS online account will be created to complete
your purchase if you are not a member or past customer.
Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, Ext 291