Good Clinical Practice (GCP) for Medical Devices
Course Description
Good Clinical Practice (GCP) refers to the regulations and requirements that must be followed while conducting a clinical trial. If a medical device firm fails to comply with these requirements it may not only jeopardize human research subject's safety, but also face FDA regulatory action leading to delay of device approval, and subsequently lost time, money and reputation in the industry. FDA has issued many GCP warning letters to medical device firms, clinical investigators and site IRBs over the past year; clearly, compliance activities are being heavily scrutinized. Thus, it is more critical than ever to adequately comply with requirements set forth by the agency. Good Clinical Practice (GCP) for Medical Devices teaches participants how to interpret the FDA regulations and guidance, identify FDA specific "hot button" compliance issues for medical devices and comply with GCP requirements. Learn how to develop concise clinical documentation, interact appropriately with an IRB and prepare for BIMO inspections. By the end of this two-day course, participants are able to practice effective study oversight, identify the roles and responsibilities of sponsors, monitors and investigators, report adverse events and more. Throughout the duration of this course, participants are given the opportunity to participate in case studies and interactive exercises to ensure that classroom learning transfers to on-the-job improvement. Don't miss this training event co-developed by PTi international and the Medical Device Manufacturers Association (MDMA)!