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Online FDA-cGMP TRAINING - Pharmaceuticals
(21CFR210-211)*

Only $229.95!

Who should take this online training?
  • You want to quickly and efficiently understand what the FDA's GMP for finished pharmaceuticals is about,
  • You want improve your résumé and career opportunities in the Pharmaceuticals and Biotechnology industry with qualifications in the GMP, by adding this industry-wide recognized course to the education or training section of your CV,
  • 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 $195.46 for group training of 10 or more employes (each student receives his own login and password) to $229.95 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 or 1.2 Continuing Education Unit (CEU) 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.

Worldwide Course Recognition:
Our 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 (SEA), or courtesy of the Federal Drug Administration (FDA).

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.

Secure AreaTHE 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
Course Outline for FDA-cGMP Pharmaceuticals Training

Course objective
This training course has been designed for individuals involved in manufacturing
of Finished Pharmaceuticals products. It offers in-depth training on the FDA's
GMP for finished pharmaceuticals requirements. With the current regulations in
US and Europe, it is critical that the pharmaceutical industry be aware of the
threat and of the guidance materials available from regulatory agencies to help
address pharmaceutical security concerns. Pharmaceutical security and training
experts from FDA and USDA wrote and approved the course.


Course length
2-3 days (a few hours everyday) are required to complete the FDA-cGMP for
Finished Pharmaceuticals Training.


Who should attend
Anyone who do not have time to allocate a full day to take a LIVE class on FDA's
GMP for finished pharmaceuticals, wants to quickly and efficiently understand
what the pharmaceutical FDA's GMP requirements are, and implement the GMP
without using a consulting firm


Course includes
The structure of the training is as follows:
• Sec. 210.3 Definitions
• Part 211 - Current good manufacturing practice for finished
pharmaceuticals
• Subpart A--General Provisions
• Subpart B--Organization and Personnel
• Subpart C--Buildings and Facilities
• Subpart D--Equipment
• Subpart E--Control of Components and Drug Product Containers and Closures http://www.caliso9000.com/
• Subpart F--Production and Process Controls
• Subpart G--Packaging and Labeling Control
• Subpart H--Holding and Distribution
• Subpart J--Records and Reports
• Subpart K--Returned and Salvaged Drug Products


Worldwide Course Recognition:
Our 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 standards and regulations are provided online under licensing of
the American National Standard Institute (ANSI), SAE International, or courtesy
of the Federal Drug Administration (FDA).


Course requirements
The training is optimized for Microsoft Internet explore 5.0 or higher and
Netscape 4.5 or higher


Certificate requirements

The course uses a continuous evaluation method with on-going quizzes to
facilitate the information retention. If your final average is equal or greater to
70% you will be issued a training certificate. If your final average evaluation is
less than 70%, you will have to take a final exam and score above 70% to be
issued the training certificate.

 
 

Courtesy of CALISO