Overview:
Complaint handling and reporting of adverse events related to the use of medical devices is a regulatory requirement in most regulated medical device markets. Yet the requirements are not the same, and the definition of ‘adverse event’ can even be different from market to market.

This course covers definitions (complaint, MDR, adverse event, investigation, etc), requirements for regulatory actions related to each, how to respond to a complaint that reports a possible adverse event, and how to report an adverse event to the regulatory authorities.

Instructional methods include: Lecture format, with questions/answers/discussion throughout. 

How you will benefit:
By the end of the course, participants will have gained:

• How to identify if a customer report is a complaint and/or a reportable event
• What the requirements are for reporting – who, what, when, how

Course Topics:

• What is a complaint?
• What is an adverse event?
• What is an MDR?
• What are the regulatory requirements for complaints – in the US? In the rest of the world?
• What are the regulatory requirements for reports – in the US? In the rest of the world?

Who Should Attend:
Anyone who is involved in complaint handling and/or adverse event reporting: R&D, Mfg, RA/QA, sales/marketing personnel.

Instructor Bio: Sheila Ramerman, RAC
Sheila Ramerman is the founder and Principal at SJR Associates, a medical device regulatory affairs, quality systems, and clinical affairs consulting practice located in Eugene, OR.  Her consulting practice puts particular emphasis on assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Her clients range from start-up companies who are developing home-testing and near-patient testing devices, to well-established, global medical device manufacturers.  Prior to founding SJR Associates, Sheila was responsible for regulatory affairs, quality systems, and/or clinical studies at small or start-up medical device companies in the San Francisco Bay Area, working with a variety of medical device technologies. Sheila has been a moderator and presenter for medical device seminars and webcasts for the Regulatory Affairs Professional Society, and has been a member of RAPS since 1995. She is a guest lecturer in the UC-Santa Cruz Regulatory Affairs Certificate Program, and has been affiliated with OBA’s BioPro WorkForce Training program since early 2007. Sheila began her career as a Medical Laboratory Technician and Clinical Laboratory Scientist in community hospital laboratories, and has worked in the medical device industry since 1989. Sheila holds an AA degree in Clinical Laboratory Technology from Shoreline Community College in Seattle, WA; a BA in Health Services Administration from Saint Mary’s College in Moraga, CA; and she has been Regulatory Affairs Certified since 1998.