FDA CFR 800 & CFR 820 for Medical Devices

Description

FDA CFR 800 & CFR 820 for Medical Devices (Introduction) eLearning Course.

Title 21 – FDA CFR 800 and CFR 820 eLearning

This Certificate Training course provides orientation training to the US FDA & the US Code of Federal Regulations (CFRs) – US CFRs, Title 21 (FDA compliance requirements for medical devices).

US FDA CFRs 800 and 820 including subparts – online training course

This training course for US FDA CFR 800 & CFR 820 helps learners understand:

• The role of the US FDA including how changing technologies impact USA FDA regulations (FDA Title 21 CFRs 800 and 820 for medical devices)
• How the US FDA may interact with sites including audit tips and CFR Title 21 / CFR 800 & CFR 820 FDA warning letter/citation trends
• How different the regulations (e.g. finished product, medical devices and biologics) are structured within the CFRs

Searching for the CFRs for Pharmaceutical products? Click here for US FDA Title 21 – FDA CFRs for Pharmaceuticals

The FDA CFRs for Medical Devices (GMP Regulations)- CFR 800 & CFR 820

Understanding the US CFR 800 & 820 (FDA Code of Federal Regulations = CFRs) can be challenging for Quality Managers and Medical Device manufacturing personnel.
This convenient online GMP eLearning course (covering FDA CFRs for Medical Devices) provides induction training or refresher training for your personnel, complete with signed and dated Certificates of Completion for your personnel and training records.

This course covers the FDA CFR 800 & CFR 820 (USA/FDA Code of Federal Regulations, CFR Title 21).

The eLearning course for FDA CFRs for Medical Devices was designed by PharmOut.

• It is based on current FDA regulations for GMP for medical devices.
• This eLearning course will introduce FDA CFRs and build on your existing knowledge of specific FDA regulations and requirements for medical devices.
• It is recommended you also complete the Recalls course for medical devices and other therapeutic products.

Other courses covering Medical Device regulations, compliance guidance and globally accepted standards include:

ISO 13485:16 Quality Management Systems (QMS) – Medical Devices

ISO 14971 –  Risk Management for Medical Devices

Who should complete this FDA CFR 800 and CFR 820 training course for medical devices being marketed in the USA?

Whether you are new to working within GMP — or an experienced person needing to develop or refresh your CFR 800 and 820 understandings — these interactive online GMP Certificate courses for the FDA CFRs will keep you engaged and up to date on your training record.

They are excellent courses to give you a foundational knowledge of GMP compliance with the FDA’s (Title 21) CFRs, Parts 800 and 820.

However, while providing a comprehensive overview of the regulations, they are designed to be completed in addition to onsite training specific to your product as well as onsite Supervision and monitoring of your GMP compliance activities, documentation practices, and onsite practices.

FDA CFRs (Title 21)

 

Introduction to FDA CFRs 800 & 820 and subparts for medical devices – Course Descriptions for FDA CFRs Title 21 (training bundle)

 

• After successful completion of each of our courses in this bundle (or other medical device industry regulatory compliance courses, online), learners will have the option of printing or saving a personalised GMP Training Certificate that meets regulatory GMP requirements.
• Prices are per course/per person and are in USD.
• The purchase price includes 12 months’ access to the core modules in this online GMP training bundle for FDA CRFs & GMP foundations.

 

Course Duration

How long will it take to complete the FDA CFRs 800 & 820 online training module designed by PharmOut?

Allow 1.5 to 2 hours to complete this course.

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Learning times and online course completion time frames for FDA CFR training courses can vary, depending on:

• Depth of each particular module
• Pre-existing knowledge of the learner
• Familiarity with the topic and/or experience with FDA regulatory compliance
• Individual learning styles
• Reading speed
• Internet speed
• Interruptions

 

Recommended pre-requisites for this GMP certificate training course:

 

• Basic understanding of GMP principles including the 10 Golden Rules of GMP
• Experience in GMP environment or basic GMP induction courses
• Where applicable, the USA FDA CFR 210 & 211 for Pharmaceutical products

The other CFR training modules are in-depth and may take an average of 2 to 3 hours to complete the course, complete the online Final Assessment, and gain your GMP Course Certificate.

You can complete 2 other online courses with this module if you opt for the GMP Training bundle discount package (10 Golden Rules of GMP and CFRs 210, 211).