GMP Medical Devices Training Class Approved By FDA Regulated Industries

GMP medical devices compliance training class and good manufacturing practices approved by FDA regulated medical industries (21CFR820)

FDA GMP Medical Device Online Training Class

This course is especially designed to meet the needs of people involved in current good manufacturing practices for MEDICAL DEVICES - Quality System Requirements -21CFR820. This course gives an in-depth understanding of the FDA and European GMP requirements. It is helpful in understanding the legal requirements and regulatory expectations relating to cGMP, as well as the costs of non-compliance.

FDA GMP Medical Device Online Training Course Length

1-2 days are required to complete the FDA GMP Medical Device online training class.

Who Should Attend FDA GMP Medical Device Class?

Any manager or employee who do not have time to allocate a full day to take a LIVE class on the GMP Quality System Requirements (QSR), wants to quickly and efficiently understand what the FDA's GMP for medical device is about, and implement the GMP without using a consulting firm.

FDA GMP Medical Device Online Training Class Includes

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
Subpart O – Statistical techniques

FDA GMP Medical Device eLearning Benefits

• Course can be taken from home or at work through the Internet
• Complete the course at your own pace
• There are no time limits so you have flexibility in taking the course around your schedule
• Use quizzes as a continuous evaluation method to facilitate course content retention
• Provide the text of FDA's-GMP for medical devices and the course is built 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].

FDA GMP Medical Device eLearning Course Approval

This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the Registrar RWTUV of Germany to support the training of their clients worldwide (http://www.rwtuvusa.com).

FDA GMP Medical Device Online Training Course Requirements

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

FDA GMP Medical Device Training Certificate

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.

For more questions about the training classes online visit our FAQs. If you are already registered, click here.

PO and DD 1556 purchases are available for corporate and Federal Government account; fax the PO to (510) 814-7318. And, online courses are provided by Caliso Consulting LLC.