Introduction to CFRs Part 800 & 820 for Medical Devices

Introduction to CFRs Part 800 & 820 for Medical Devices

USD $30.00

Course duration: Allow 1.5 to 2 hours to complete this course.

Description

GMP training course for US FDA CFRs 800 and 820

Introduction to FDA CFRs (GMP Regulations) CFRs 800 and 820

This Certificate Training course provides orientation training to the US FDA and the Code of Federal Regulations (CFRs).

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

This training course for US FDA CFRs 800 and 820 helps learners understand:

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

The FDA CFRs (GMP Regulations) and CFRs 800 and 820

Understanding the US Code of Federal Regulations (CFRs) can be challenging for Pharmaceutical personnel, Quality Managers and Medical Device manufacturers.

Fortunately, this convenient online GMP (FDA CFRs) induction and FDA CFRs refresher training package (including GMP foundations, all available online) is an excellent induction course as well as a CFR refresher training course.

This course covers current FDA CFRs 800 and 820 (USA/FDA Code of Federal Regulations, CFR Title 21).


The FDA CFRs training course, designed by PharmOut and based on current FDA regulations for GMP for medical devices, is designed to introduce and build your knowledge of the specific FDA regulations (the United States Code of Federal Regulations) for these types of medical-use products.


Who should complete this FDA CFRs 800 and 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 CFRs (Title 21) – 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.


Descriptions for FDA CFRs Title 21

Introduction to FDA CFRs 800 & 820 and subparts for medical devices

Online Course Descriptions for FDA CFRs Title 21 (training bundle for Parts 800 and 820)

  • After successful completion of each of our courses, learners will have the option of printing or saving a personalised GMP Training Certificate that meets regulatory GMP requirements.
  • Prices per course are per person, in USD.
  • This price includes 12 months of access to the three core modules in this online GMP training bundle for FDA CRFs and GMP foundations.

FDA CFRs Title 21 - FDA CFRs 210-211, CFR 800, CFR 820 and subparts FDA GMP regulations training course


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.

Learning times and online course completion time frames for our bundle of FDA CFR foundations training courses are variable depending on:

  • Depth of each particular module
  • Pre-existing knowledge of the learner
  • Familiarity with the topic and/or with GMP principles
  • Learning styles
  • Reading speed
  • Interruptions

Recommended pre-requisites for this GMP certificate training course:

  • Basic understanding of GMP principles including 10 Golden Rules
  • Experience in GMP environment or basic GMP induction courses
  • Introduction to the FDA and to the USA FDA CFRs (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). 

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