ISO 13485:2016 certification

MEDICAL DEVICE GMP, cGMP, GMP TRAINING, GMP COURSE, 21CFR820, QSR

FOOD GMP REGISTRATION

Online 21CFR820 cGMP Course ($249.95)


This course includes the 2016 update of the QSR and incorporates the unique device identifier (UDI) requirement issued by the FDA.

The FDA requires employees to be trained in the current GMP as it relates to the employee's functions to help assure the safety and efficacy of drug products.

-You want to quickly and efficiently understand what the April 1, 2016 version of FDA's cGMP 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 cGMP economically and without having to immobilize them in a class for a full day,

-you are ISO 13485 certified and need to comply with FDA requirements,

-you want to implement the GMP without using a consulting firm,

the FDA's GMP for medical devices online course is the solution:

  • The GMP course can be taken from anyone's workplace or from home through the Internet with no time limit on when a registered trainee can start or finish. The certificates and courses are accessible online during 3 years.
  • 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 $212.46 for group training to $249.95 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, 2016, 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. Quizzes can only be taken once, and once completed cannot be accessed.
  • 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.

Guarantee:

Your satisfaction is guaranteed. If you register to any of our online courses and are not satisfied with the content, let us know within 30 days of registration, and BEFORE you complete the course or are issued the online certificate: we will refund 100% of the registration fee. We are confident, that like our many other trainees, you will like any course we offer, take some of our other courses, and also recommend them to others. We are proud of our achievement, and want to show it through the explicit satisfaction guarantee that other trainers cannot offer.

ISO 13485:2016 TESTIMONIALS

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 20,000 trainees in the US and worldwide. The standards and regulations are provided online under licensing agreements.


Employees of some of the following corporations are using our online courses:

ISO 13485 ABBOT ISO 13485 PHILLIPS ISO 13485 GE ISO 13485 BAXTER ISO 13485 FDA ISO 13485 J JISO 13485 ROCHEISO 13485 OLYMPUS ISO 13485 STERIPACK ISO 13485 NOKIA

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. 

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.
 

To take the training:

  1. Go to the pre-signup screen (http://www.caliso9000.com/courses/21CFR820-GMP/PreSignUp.asp), select a User ID that you can remember easily, enter your password and invoice #. 
  2. If you are part of a group of users, go to the signup screen (http://www.caliso9000.com/courses/21CFR820-GMP/SignUp.asp), and enter your personal information that will be used in the training certificate. 
  3. Go to the login screen; enter your User ID and password. 
  4. You will be presented with training slides followed by quizzes, after taking a quiz, click on the score button to proceed. 
  5. You cannot retake quizzes again, but you can go back and look at previous slides by using the "Previous" button. 
  6. You have help buttons for each quiz question, and documentation examples for each training slide. 
  7. Unless otherwise designated, all quiz questions are within the context of the FDA's medical device cGMP . 
  8. The training is optimized for recent Internet browsers. To access videos your browser needs to allow Youtube access and popups.


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:

Download the course outline

Go to pricing and registration information

Go directly to training Login screen

Forgot your User ID or Password or Invoice Number