US FDA GMP Training – introduction to CFRs FDA Regulations
This course bundle is designed to introduce and build your knowledge starting with engaging basic GMP, introduce the US Code of Federal Regulations (CFRs) and the role of the Food and Drug Authority (FDA) through to CFRS 210 and 211 for finished pharmaceuticals and 800 and 820 for medical devices.
Who should complete this Bundle?
Whether you are new to working within GMP or an experienced person needing to develop or refresh your CFR 210, 211, 800 and 820 understanding, these interactive eLearning courses will keep you engaged.
Module 1: The 10 Golden Rules of GMP
This interactive e-Learning course provides a straightforward guide to Good Manufacturing Practice (GMP). It is useful for all personnel who work within a GMP regulated environment.
- Get the facility design right, from the start
- Validate processes
- Write good procedures and follow them
- Identify who does what
- Keep good records
- Train and develop staff
- Practice good hygiene
- Maintain facilities and equipment
- Build quality into the whole product life cycle
- Perform regular audits
Module 2: Introduction to CFRs 800 & 820 for medical devices
This interactive e-Learning course 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
- how different the regulations (e.g. finished product, medical devices and biologics) are structured within the CFRs
Module 3: Introduction to CFRs 210 & 211 for finished Pharmaceuticals
This interactive e-Learning course provides personnel with the key concepts in CFRs Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General, and Part 211: cGMP for Finished Pharmaceutical.
The course is linked to the FDA warning letter findings and will assist new QA and supervisory personnel navigate these length regulations.
After successful completion of each course in the bundle the trainee will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.
Bundle price is per person and includes 12 months access to the three core modules