compliance-with-FDA-CFrs-guidelines

Introduction to FDA CFRs 210, 211 and CFRs 800 & 820 (Training Bundle)

USD $120.00

Course duration: Allow approximately 4 to 6 hours to complete all 4 courses in this training bundle.

 

 

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SKU: US FDA GMP Training Bundle Category:

Description

US FDA CFRs – FDA GMP Compliance Training Bundle

Introduction to FDA CFRs (GMP Regulations) CFRs 210, 211, 800 and 820

This interactive online training course (designed by PharmOut) provides a straightforward introduction to both the US FDA CFRs (210 & 211 and 800 & 820 (FDA Code of Federal Regulations).

PharmOut’s FDA CFR regulations online training course includes 4 online regulatory compliance training modules:

 

 

Why take these courses?

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

Fortunately, these convenient online cGMP training courses (FDA CFRs induction & refresher training packages (online) cover current FDA CFRs (USA/FDA Code of Federal Regulations).

    • This online training course for US regulations for medical devices and pharmaceutical products (FDA CFRs 210, 211, 820 and 822), designed by PharmOut, is based on current USA FDA regulations for pharmaceutical products and medical devices (CFRs).
    • It 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.

Starting with engaging basic GMP principles (the 10 Golden Rules of GMP), we will introduce you to the US Code of Federal Regulations (CFRs) and the role of the Food and Drug Authority (FDA), through to CFR 210 and CFR 211 for finished pharmaceuticals and CFR 800 and CFR 820 for medical devices.

Who should complete this GMP Training Bundle on FDA CFRs and regulations for medical devices and finished pharmaceuticals?

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.

 

Online Course Descriptions – FDA CFRs Training Options

Online compliance training for FDA CFRs Title 21 (training bundle for Parts 210, 211, 800 and 820):

 

Module 1: The 10 Golden Rules of Good Manufacturing Practice (cGMP)

This interactive eLearning course provides a straightforward guide to current Good Manufacturing Practice (cGMP). It is useful for all personnel who work within a cGMP-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

Compliance guidelines for FDA CFRs 210, 211, CFR 800, 820 regulations-Subparts

 

Module 2: 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

 

Module 3: Introduction to FDA CFRs 210 & 211 for finished Pharmaceuticals

This interactive eLearning course provides personnel with the key concepts in CFR 21, Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General, and CFR 21, Part 211: cGMP for Finished Pharmaceutical.

The course is linked to the FDA warning letter findings and will assist new Quality Management and Supervisory personnel navigate these lengthy regulations.

FDA CFRs Code Of Federal Regulations - CFR

 

Module 4: Good Recordkeeping Practice (GRK)

This interactive eLearning course provides personnel with information on the key requirements for compliance with Good RecordKeeping Practice (GRK), also known as ‘good documentation practice/GDocP’.

This module includes an overview of AlCOA/ALCOA+ requirements and common gaps in recordkeeping compliance (audit findings) for pharmaceutical and medical device manufacturing personnel and their suppliers.  Note: Good recordkeeping practice requirements are applicable to all manufacturing personnel and contractors, facility/equipment maintenance workers, quality managers and administrators working on procedural documents and work instructions, pharmaceutical products warehouse contractors/employees, distribution workers/transport drivers security guards, and logistics personnel.

 

GMP Courses designed by PharmOut

After successful completion of each PharmOut PTY LTD designed training course in the FDA CFRs compliance training bundle, learners will have the option of printing or saving a personalised GMP Training Certificate that meets regulatory GMP requirements.

The bundle price for GMP eLearning is per person and is listed in USD. This price includes 12 months’ access to the core modules in this online GMP eLearning training bundle for the FDA CRFs & related GMP foundation modules.

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 these FDA CFR training modules 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
  • Interruptions

Course duration:

Allow approximately 4 to 6 hours to complete all 4 courses in this online CFRs/GMP compliance training bundle.

Note:

Most courses in this training bundle can be completed within 1 hour to 2.5 hours (average). But courses do vary in duration.

  • The GMP 10 Golden Rules is typically only a 30-minute induction-style course.
  • However, the other CFR training modules are in-depth and may take an average of 1 hour to 2 or 3 hours each to complete the training and the online Final Assessment required to gain the GMP Course Certificate of Completion.

Resources: FDA GMP Regulations

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