Introduction to CFR 210, 211

Introduction to CFR 210, 211

$80.00

This interactive e-Learning course provides a straightforward introduction to both the US FDA and the Code of Federal Regulations (CFRs):

  • The 10 Golden Rules of GMP
  • Introduction to CFRs and the FDA
  • Introduction to CFRs 210 & 211 for Finished Pharmaceuticals

 

 

 

SKU: US FDA GMP Training Bundle Category:

Description

US FDA GMP Training – introduction to CFRs 210, 210 

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.

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 and 211 understanding these interactive eLearning courses will keep you engaged.

Module Descriptions:

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
  • Practise good hygiene
  • Maintain facilities and equipment
  • Build quality into the whole product life cycle
  • Perform regular audits

Module 2: Introduction to CFRs and the FDA

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 2015 top 10 FDA warning letter findings and will assist new QA and supervisory personnel navigate these length regulations.

Certification

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