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 FDA's GMP for medical devices online course is the solution:
Worldwide Course Recognition:
CALISO online training courses are recognized by all registrars and hiring companies as objective evidence of effective training on the particular standard and regulation. Since 1999, they have been the most popular and most widely used training courses in English, with over 20,000 trainees in the US and worldwide. The standards and regulations are provided online under licensing agreements.
"I just completed the Interactive online training for the GMP. I liked the fact that I was able to take the class at my convenience from my desk at work. I was able to allocate a few hours over a 4-day period to take the class. The layout of the on-line training was easy to follow. All of the standard requirements were in italics and an easy-to-understand "translation" could be found directly underneath. Also, since each section was followed by a short quiz the entire process didn't feel overwhelming."
Hagmann - ISO Coordinator of Biosurgical
cost-effective uniform training for a management and
sales staff that is located world-wide is difficult at
best. Arranging travel and schedules to ensure that
everyone can get to the training is next to impossible.
Jerry Bunch -
Senior Quality Manager of Boundless Manufacturing
Upon registration using Visa, America Express, or MasterCard you will receive an invoice, and an E-mail notification with the password and link to login and take the class. PO and DD 1556 purchases are available for corporate and Federal Government account; fax the PO to (509) 756-6053.
THE TRANSACTION IS SECURE: The credit card registration is done through a secure socket, so there is no risk for your credit card information, which is protected and cannot be intercepted.
If you register
multiple users you will receive a password for each one
To take the training:
if your connection is slow, do not click on buttons such
as "Submit", "Login" or
-Empty your browser disk cache on a regular basis to optimize the performance of your browser.
-For ease of readability select "Verdana" as your display font.
-Do not disable cookies. If you are planning to leave the training for more than 20 minutes, "Save and Exit". The training session times-out after 20 minutes of inactivity.