This interactive e-learning course provides a straightforward introduction to both the US FDA and the Code of Federal Regulations (CFRs) for FDA CFRs 800 and 820.
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
Introduction to FDA CFRs (GMP Regulations) 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) 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.
Online Course Descriptions for FDA CFRs Title 21 (training bundle for Parts 800 and 820)
Introduction to FDA CFRs 800 & 820 for medical devices
(CFR Title 21 – Part 800 and Part 820 including Subparts)
This interactive online Certificate GMP Course designed by PharmOut provides a straightforward introduction to both the US FDA and the Code of Federal Regulations (CFRs). This course explains:
- the role of the US FDA including how changing technology impacts regulations
- how the US FDA may interact with your site including audit tips and warning letters (recent FDA citations for medical devices)
- how different FDA regulations (e.g. for finished pharmaceutical products, medical devices and biologics) are structured within the CFRs
GMP Certificate Courses designed by PharmOut
After successful completion of each course in the bundle, 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 access to the three core modules in this online GMP training bundle for FDA CRFs and GMP foundations.
Online Training Course – Average completion time/course duration
How long will it take to complete the FDA CFRs 800 & 820 online training module designed by PharmOut?
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
In general, allow from 1 to 3 hours per FDA CFR topic courses.
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.