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MEDICAL DEVICE GMP, cGMP, GMP TRAINING, GMP COURSE, 21CFR820, QSR
Online Medical Device GMP Training-21CFR820 ($189.95)
Links to the
Pharmaceuticals GMP, the
Food GMP, the Good Laboratory Practices (GLP), and the
ISO 13485:2003 course.
-You want to quickly and
efficiently understand what the FDA's GMP 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 GMP economically and
without having to immobilize them in a class for a full
day,
-you want to
implement the GMP without using a consulting firm,
the FDA's GMP for medical devices online course is the solution:
download the course outline
- 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.
- 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 $161.46 for group training to $189.95
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, 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.
- 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.
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), the American Society of Automotive Engineer
(SAE), or courtesy of the Federal Drug Administration (FDA).
Employees of some of the following corporations are using this online course:
Testimonial:
"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."
Julie C.
Hagmann - ISO Coordinator of Biosurgical
Corporation-Pleasanton Division
"..Providing
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.
After
researching a number of online training solutions, I
found CALISO's program to offer the best bang for the
buck."
Jerry Bunch -
Senior Quality Manager of Boundless Manufacturing
Services
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
of them.
To take the
training:
- Go to the
pre-signup screen (http://www.caliso9000.com/courses/mGMP/PreSignUp.asp), select a User
ID that you can remember easily, enter your
password and invoice #.
- If you are
part of a group of users, go to the signup screen
(http://www.caliso9000.com/courses/mGMP/SignUp.asp), and enter
your personal information that will be used in
the training certificate.
- Go to the
login screen; enter your User ID and password.
- You will
be presented with training slides followed by
quizzes, after taking a quiz, click on the score
button to proceed.
- You cannot
retake quizzes again, but you can go back and
look at previous slides by using the
"Previous" button.
- You have
help buttons for each quiz question, and
documentation examples for each training slide.
- Unless
otherwise designated, all quiz questions are
within the context of the FDA's medical device cGMP .
- The
training is optimized for Microsoft Internet
Explorer 5.0+ and Netscape 4.5+
User
Recommendations:
-Even
if your connection is slow, do not click on buttons such
as "Submit", "Login" or
"Score" twice.
-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.
User Links:
Go to pricing and registration information
Go directly to training Login screen
Never chose a User ID and forgot your Password and/or Invoice Number
Already logged in before and forgot your User ID and/or Password
Consult the Quality System Requirements -21CFR820 for Medical Devices (QSR)
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