|
|
Online
FDA-cGMP TRAINING
-
Pharmaceuticals
(21CFR210-211)* |
|
Only $299.95 !
|
|
|
Who should
take this online training?
-
You want to quickly and efficiently
understand what the FDA's GMP for
finished pharmaceuticals is about.
-
You do NOT have time to allocate a
full day to take a LIVE class on the
GMP requirements and 21CFR210 and 211.
-
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 finished
pharmaceuticals online course is the
solution:
-
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 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 $237.96 for
group training to $279.95 for
individual training. This is an
average 60% 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 cGMP
for finished pharmaceuticals (in
dark blue) and uses quizzes to give
guidance in implementation of the
requirements. 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: 21CFR211]. .
-
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 training
certificate that you can print
for 12 hours of training on the cGMP
for finished pharmaceuticals.
-
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.
Course
approvals:
Course approvals
for this pharmaceuticals FDA cGMP
online course:
 |
The training is approved by the
German Registrar RWTUV. The
certificate bears all the
approvals. |
Employees
of some of the following corporations are using this
online training:
Philips Medical, Baxter Healthcare,
Bayer, Monsanto, Allegan, Estee Lauder.....
|
|
|
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 Baxter Healthcare
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 |
|
|
|
|
Signup
& Training Instruction |
|
Step
1
|
REGISTRATION
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
accoun; fax the PO
to (714) 484-3014.
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. |
|
Step
2
|
Go
to the
PRE-SIGNUP
SCREEN,
select a User ID that you can remember easily, enter your password and invoice #. |
|
Step
3
|
If
you are part of a group of
users, go to the
SIGNUP
SCREEN,
and enter your personal information that will be used in the training certificate. |
|
Step
4
|
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
finished
pharmaceuticals
cGMP.
-
The
training is optimized for Microsoft
Internet Explorer 5.0+ and
Netscape
4.5+
|
|
|
|
Suggestions
and Recommendations:
-
Even
if your connection appears
to be slow, do not click
on buttons such as
"submit",
"Login" or
"Score" twice.
Some browsers don't handle
the double clicking
well...
-
Empty
your 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.
-
View copies of the
cGMP standards
from
FDA's website
|