LIVE IN PERSON SEMINAR BY FORMER CHIEF OF FDA CDRH 2015 - Effective Complaint Handling, Medical Device Reporting and Recalls -- Avoiding Costly Errors: One and a Half-day In-person Seminar

Website http://bit.ly/1zrVXzW | Edit Freely

Category FDA GXP Compliance - Medical Devices;

Deadline: February 05, 2015 | Date: February 05, 2015-February 06, 2015

Venue/Country: Tampa, United Arab Emirates

Updated: 2014-12-23 15:45:17 (GMT+9)

Call For Papers - CFP

During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.