Uncovering and Managing Successful Postmarket Compliance for Medical Devices: Complaint Handling, Medical Device Reporting, and Recalls

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.

Customer 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 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 from 15 July to 11 August  
RAPS Members: $900 
Nonmembers:  $1000

NOTE: Advance registration is required for this workshop, therefore, participants are encouraged to register early. 

Registration Form

Wednesday, 12 August (9:00 am – 5:00 pm EDT) 

• 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 (9:00 am – 5:00 pm EDT) 

• 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, Regs & Recall Strategices, LLC

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.

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 via our online cancellation form. 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 following the conclusion of the workshop.