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MEDICAL DEVICE GMP, cGMP, GMP TRAINING, GMP COURSE, 21CFR820, QSR
Online Medical Device GMP Training-21CFR820 ($179.95)
The FDA approval class can be taken from anyone's workplace or from home through the Internet without any time limit to complete the course.
"save and exit" features so that you
can do it at your own pace (a couple of sections
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.
ranges from $152.96 for group training to $179.95
for individual training. This is an average 50%
cost savings on comparable class courses.
training uses examples and quizzes that give very
good exposures on industry related implementation
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, 2003, 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.
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.
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
GMP Overview video
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 15,000 trainees in the US and worldwide. The standard and regulations are provided online under licensing of the American National Standard Institute (ANSI), SAE International, or courtesy of the Federal Drug Administration (FDA).
Employees of some of the following corporations are using this online course:
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 requiremen 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.
researching a number of online training solutions, I
found CALISO's program to offer the best bang for the
Jerry Bunch -
Senior Quality Manager of Boundless Manufacturing
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
accoun; 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
Go to the
login screen; enter your User ID and password.
be presented with training slides followed by
quizzes, after taking a quiz, click on the score
button to proceed.
retake quizzes again, but you can go back and
look at previous slides by using the
help buttons for each quiz question, and
documentation examples for each training slide.
otherwise designated, all quiz questions are
within the context of the FDA's medical device cGMP .
The training is optimized for recent Internet browsers
if your connection is slow, do not click on buttons such
as "Submit", "Login" or
your browser disk cache on a regular basis to optimize
the performance of your browser.
ease of readability select "Verdana" as your
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.