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Online FDA-cGMP TRAINING - Medical Devices
(Quality System Requirements - 21CFR820)

(Only $189.95!)

Who should take this online training?
  • You want to quickly and efficiently understand what the 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 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 training is the solution:
  • 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 trainingcertificate 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.

Course approvals:

The training is approved by the German Registrar TUV-Essen. The certificate bears all the approvals.

*Selected by the prestigious ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide in 7 languages.


 

Employees of some of the following corporations are using this online training:
Philips Medical, Baxter Healthcare, Bayer, .....

Testimonial:

"I 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 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. 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.
Ensuring 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.
After researching a number of online training solutions, I found your 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 (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.

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 ISO 13485:2003 and ISO 9004:2000. 
  • 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.
  • If you get an "Invalid Amount" message during registration, try a different credit card first. Some credit cards do not allow certain e-business transactions.
  • Order copies of the ISO/TS 13485:2003 standards from American National Standards Institute
Course Outline for FDA-cGMP Medical Devices Training

Course objective
It has been specifically designed to meet the needs of people involved in current good manufacturing practices for medical devices. This course gives an in-depth understanding of the FDA and European cGMP requirements. It is helpful in understanding the legal requirements and regulatory expectations relating to cGMP, as well as the costs of non-compliance.

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

Who should attend?
Anyone who do not have time to allocate a full day to take a LIVE course on the cGMP Quality System Requirements (QSR), wants to quickly and efficiently understand what the FDA's GMP for medical devices is about, or wants to implement the GMP without using a consulting firm.

The structure of the training is as follows:

PART 820--QUALITY SYSTEM REGULATION
Subpart A General Provisions
Subpart B Quality System Requirements
Subpart C Design Controls
Subpart D Document Controls
Subpart E Purchasing Controls
Subpart F Identification and Traceability
Subpart G Production and Process Controls
Subpart H Acceptance Activities
Subpart I Nonconforming Product
Subpart J Corrective and Preventive Action
Subpart K Labeling and Packaging Control
Subpart L Handling, Storage, Distribution, and Installation
Subpart M Records
Subpart N Servicing


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 (SAE), 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