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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
satisfaction plays a significant role in measuring a product’s postmarket
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 postmarket 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-threatening 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 postmarketing of medical
NOTE: Advance registration
is required for this workshop, therefore, participants are encouraged to register
Wednesday, 12 August (9:00 am – 5:00 pm EDT)
Thursday, 13 August (9:00 am – 5:00 pm EDT)
agenda may vary based on changing requirements.
Rita Hoffman, RAC is an expert on postmarketing compliance issues, having spent over 37 years with the FDA prior to entering the world of regulatory consulting. Prior to retiring from the FDA in 2011, she served as the recall branch chief for the Center for Devices and Radiological Health (CDRH) and was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst.
This unique combination of experience gives Ms. Hoffman a diversified body of knowledge encompassing FDA scientific, investigational and regulatory policy and compliance areas from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products. She has served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Ms. Hoffman holds a BS from the University of Maryland and has received many additional awards from both government and industry including the FDA Distinguished Government Service Award and Outstanding Service Awards for her Compliance work and industry contributions.