(Quality System Requirements)
take this online training?
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
GMP 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
the FDA's GMP for medical devices
online training is the solution:
The training is approved by the German
Registrar TUV-Essen. The certificate
bears all the approvals.
It 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 are 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 $152.96 for
group training to $179.95 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
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
If your final average in the ongoing
evaluation is equal or greater to
70% you will be issued a training
certificate that you can print
for 8 hours of training 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
of some of the following corporations are using this
*Selected by the prestigious ISO
9000 Registrar RWTUV of Germany to
support the training of their
clients worldwide in 7 languages.
Philips Medical, Baxter Healthcare,
just completed the Interactive online training for
the new ISO 9000:2000 Standard. 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
C. Hagmann - ISO Coordinator of Baxter Healthcare
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. Your
online training provides a comprehensive program
that allows our management team the flexibility to
take the ISO 9000:2000 training on their own
schedules, while providing documentable evidence
of the training.
that Senior management understands their role in
the updated standard is the first step in ensuring
the success of our transition from ISO 9000:1994
to ISO 9000:2000.
researching a number of online training solutions,
I found your program to offer the best bang
for the buck."
Bunch - Senior Quality Manager of Boundless
& Training Instruction
registration using Visa, America Express, or MasterCard (PO
purchases are available for
corporate accounts), you will
receive an invoice, an E-mail notification with the password to be
used to login to take the class. Fax the PO to (714) 484-3014.
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
register multiple users, you will receive a password for each one of
select a User ID that you can
remember easily, enter your
password and invoice #.
you are part of a group of
users, go to the
and enter your personal
information that will be used
in the training certificate.
enter your User ID and
will be presented with
training slides followed by
quizzes, after taking a quiz,
click on the score button to
cannot retake quizzes again,
but you can go back and look
at previous slides by using
have help buttons for each
quiz question, and
documentation examples for
each training slide.
otherwise designated, all quiz
questions are within the
training is optimized for Microsoft
Internet Explorer 5.0+ and
if your connection appears
to be slow, do not click
on buttons such as
Some browsers don't handle
the double clicking
your disk cache on a
regular basis to optimize
the performance of your
For ease of
as your display
Do not disable
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.
you get an "Invalid
during registration, try a
different credit card
first. Some credit cards
do not allow certain
copies of the ISO/TS
standards from American