GMP for Medical Devices — the first of its kind program from FDAnews and GMPtraining.com — explains all the key GMP requirements for manufacturing medical device products.
Perfect for new employees the program explains the term medical device and the medical device classification system while also providing additional information on working in a regulated environment, a history of medical device regulations and a detailed discussion of the GMP requirements.
Use GMPs for Medical Devices to:
Introduce new hires to the GMP concept; teach the basic concepts and why GMPs are important
Save time and work on preparing and conducting training
Educate individuals as they are hired; no waiting for a group to make training worth the effort
Explain GMP to visitors of your plant
At the end of this program, participants will be able to:
Define the term Medical Device
Recognize Medical Device Classifications
Describe a regulated environment
State who controls the medical device environment
Recall major events in the History of Medical Device Regulations
Describe how the Quality System Regulation works
Describe key GMPs and the Role of Every Employee
Describe key Benefits of Following GMPs
GMPs for Medical Devices is available in two formats:
A 2-disc set that includes a 15-minute video presentation, Leader’s Guide, discussion guide and assessment to be used when training a group; and
A single-disc eLearning course that can be completed individually, perfect for those times when you have only one or two people to train.