Course curriculum

  • 1

    Welcome to the course!

    • How to use this course

  • 2

    General Provisions

    • FDA 21 CFR 820 CGMP Requirements _Lesson-01

    • FDA 21 CFR 820 CGMP Requirements _Lesson-01-QUIZ

  • 3

    Quality System Requirements

    • FDA 21 CFR 820 CGMP Requirements _Lesson-02

    • FDA 21 CFR 820 CGMP Requirements _Lesson-02-QUIZ

  • 4

    Design Controls

    • FDA 21 CFR 820 CGMP Requirements _Lesson-03

    • FDA 21 CFR 820 CGMP Requirements _Lesson-03-QUIZ

  • 5

    Document Controls, Purchasing Controls, and Identification and Traceability

    • FDA 21 CFR 820 CGMP Requirements _Lesson-04

    • FDA 21 CFR 820 CGMP Requirements _Lesson-04-QUIZ

  • 6

    Production and Process Controls

    • FDA 21 CFR 820 CGMP Requirements _Lesson-05

    • FDA 21 CFR 820 CGMP Requirements _Lesson-05-QUIZ

  • 7

    Acceptance Activities, Nonconforming Product, Corrective and Preventive Action

    • FDA 21 CFR 820 CGMP Requirements _Lesson-06

    • FDA 21 CFR 820 CGMP Requirements _Lesson-06-QUIZ

  • 8

    Labeling and Packaging Control, Handling, Storage, Distribution and Installation

    • FDA 21 CFR 820 CGMP Requirements _Lesson-07

    • FDA 21 CFR 820 CGMP Requirements _Lesson-07-QUIZ

  • 9

    Records, Servicing, and Statistical Techniques

    • FDA 21 CFR 820 CGMP Requirements _Lesson-08

    • FDA 21 CFR 820 CGMP Requirements _Lesson-08-QUIZ

  • 10

    Next steps

    • Congratulations

Learning Objectives

Upon completion of this training, students will be able to:

  • Understand the requirements of the FDA 21 CFR Part 820 Quality System Regulations

  • Understand quality system definitions, concepts, and guidelines

  • Understand the roles and responsibilities to support CGMP compliance

  • Apply CGMP principles and best practices

e-Course Benefits:

Amazing content | 100% online | Exceptional value

  • Eliminate travel and lodging expenses

  • Save time by attending course On Demand, anytime, anywhere, with any device

  • Communicate in real-time with your course instructor - ask questions, get clarification, and contribute your insights

  • Learn through exercises and case study

  • Receive a globally-recognized certificate for successfully completing the course

Who should attend?

  • Any individual requiring a working knowledge and understanding of FDA 21 CFR Part 820 QSR

  • Quality and Regulatory Professionals and Consultants

  • Presidents/Vice Presidents/CEOs

  • ISO Coordinators/Management Representatives

  • Engineers

  • Supervisors

  • Laboratory quality professionals

  • Accredited auditors requiring the competency to audit Quality Management Systems

FDA 21 CFR 820 cGMP Requirements

Get your CERTIFICATE OF COMPETENCE today!

Bonus material

  • QUICK FACTS: Top-5 FDA 483 Inspection Observations

    $100 value

    Learn the Top-5 US-FDA 483 Observations to help you prepare for routine FDA establishment inspections and establish robust regulatory quality compliance to FDA 21 CFR Part 820 Quality System Regulation.

Additional products

Training On Demand™