Beach Volleyball at Huntington Beach
Date: Thursday, July 13, 2017
Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA
According to FDA's published data for last year, 91% of all Medical Device Warning letters had at least one CAPA related citation and 70% of the top seven FDA 483 inspection observations were directly related to Complaint Handling, MDRs, or CAPA. FDA will scrutinize your CAPA system during your next inspection and you must to be prepared. When properly implemented, Complaint Handling and Medical Device Reports (MDRs) are usually a manufacturer's first alert to product issues that may result in a correction, removal or recall - which is why FDA is so concerned about these activities. Complaint Handling, Medical Device Reporting (MDR), and Corrective & Preventative Activities (CAPA) compliance are critical to the survival of all device manufacturers. The majority of FDA Warning Letters and serious enforcement actions, including criminal & civil penalties have been levied on companies that failed to properly report events and take proper corrective actions. Additionally, product liability and financial risks are staggering when companies fail to properly report and take corrective action when required. Understanding what constitutes a complaint and when & how it needs to be reported as a formal Medical Device Report (MDR) is very important and will be discussed in detail with examples. This course will provide an understanding of the interrelationship of Complaint Handling, Medical Device Reporting, CAPA, and the Risk Management processes. This course will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in complaint handling, medical device reporting (MDR), correction & removal processes (CAPA), and recall decisions. Jim Kozick, previous Director of Domestic Investigations, FDA Los Angeles District Office will be an instructor along with Christine Posin, a medical device industry expert specializing in helping medical device manufacturers with Complaint Handling, MDR and Recall issues.
What you will learn:
Benefits of Attending:
: Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.
Be sure to reserve your space and room early!