Medical Device GMP $399.95
This course includes the 2016 update of the QSR and incorporates the unique device identifier (UDI) requirement issued by the FDA.
- The FDA requires employees to be trained in the current GMP as it relates to the employee's functions to help assure the safety and efficacy of drug products.
- You want to quickly and efficiently understand what the April 1, 2016 version of FDA's cGMP for medical devices is about,
- You do NOT have time to allocate a full day to take a LIVE class on the cGMP Quality System Requirements (QSR),
- You want to train more of your staff on the cGMP economically and without having to immobilize them in a class for a full day,
- You are ISO 13485 certified and need to comply with FDA requirements,
- You want to implement the GMP without using a consulting firm,
- The GMP course can be taken from anyone's workplace or from home through the Internet with no time limit on when a registered trainee can start or finish. The certificates and courses are accessible online during 3 years.
- It has "save and exit" features so that you can do it at your own pace (a couple of sections per day...).
- After registration, there is no time limit on when you can start or complete the course. You have complete flexibility in taking the course around your schedule.
- The cost ranges from $339.96 for group training to $399.95 for individual training. This is an average 50% cost savings on comparable class courses.
- The training uses examples and quizzes that give very good exposures on industry related implementation issues.
- It provides the text of FDA's GMP for medical devices (in dark blue) and uses quizzes to give guidance in implementation of quality systems. The Code of Federal Regulations Title 21, Volume 8 Revised as of April 1, 2016, can be obtained from the U.S. Government Printing Office via GPO Access [CITE: 21CFR820].
- It uses a continuous evaluation method with on-going quizzes to facilitate the information retention. Quizzes can only be taken once, and once completed cannot be accessed.
- If your final average in the ongoing evaluation is equal or greater to 70% you will be issued a cGMP training certificate that you can print for 8 hours of training or .8 Continuing Education Unit (CEU) on the cGMP for medical devices.
- If your final average in the ongoing evaluation is less than 70%, you will have to take a final exam and score above 70% to be issued the training certificate.