Gxp Compliance Jeopardy Jeopardy Template

Customer Appreciation	FDA All Day	GXP State of Mind	Regulation Nation	Device Advice
100 Where is the new Cordis distribution center located? Kuehne + Nagel Inc. 4080 Executive Dr, Suite 100 Southaven, MS 38672, USA	100 What is the FDA? a federal agency of the Department of Health and Human Services.	100 What is GXP? ‘good practice’ guidelines and regulations created to ensure that food, medical devices, drugs and other life science products are safe	100 What does a license demonstrate? Demonstrates the applicant has undergone an extensive review and deemed compliant to handle, distribute and warehouse pharmaceutical products.	100 What is a medical device? Any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of: Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
200 What types of medical device products does Cordis manufacturer? Cardiovascular & endovascular solutions.	200 What regulation does the FDA enforce? Federal Food, Drug, and Cosmetic Act (FD&C),	200 What does the "X" in GXP stand for? GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GLP (Good Laboratory Practice) and many more.	200 What is downstream verification? When the recipient of the shipment checks the shipper’s license to ensure the products are coming from a legitimate source	200 What is a UDI? A unique numeric or alphanumeric code that consists of two parts a device identifier (DI) and production identifier (PI)
300 What is Cordis' Mission Statement? "delight customers by developing differentiated solutions at pace that improve patient vitality and help lower the cost of care"	300 What products does the FDA regulate? drugs, medical devices, biologics, foods, dietary supplements, tobacco, animal health products, electronic products that give off radiation, cosmetics	300 What are the 5 Ps of GXP? People, products, processes, procedures, premises & equipment.	300 What is required before issuance of an in-state license? An inspection is required before this is issued.	300 What devices carry the highest risk? Class III
400 What is the number of countries that Cordis sell products in? 70 Countries	400 How many medical device product categories does the FDA oversee? 6,700	400 What is a SOP? A procedure specific to the business operation that describes established or prescribed methods to be followed routinely for the performance of designated operations.	400 What is a Designated Representative? A responsible individual associated with the facility licenses	400 Who are the US Regulatory Authorities for Medical Devices? FDA & State Regulatory Boards
500 What does Cordis never stop doing? Innovating	500 Who is the current commissioner of the FDA? Robert Califf	500 How do regulatory agencies certify adherence to GDP (good distribution practices)? Inspection, auditing and licenses	500 What is re-packaging, re-labeling and kitting? These are considered to be manufacturing activities and a FDA registration is required.	500 What is a 510(K) submission? This is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device

GXP COMPLIANCE JEOPARDY

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