Online & Self-Paced U.S. FDA Quality Systems Regulation (QSR) 21 CFR 820 Course

★★★★★

  • Course Area:

    Medical Devices

  • Course Duration:

    8 Hours

  • Format:

    Online & Self-Paced Course

  • Accreditation:

    CQI and IRCA approved training partner
  • Individual Pricing:

    Not Yet Available

  • Team Pricing:

    Need more! Call us

Finally, an industry-leading online, blended & virtual training solution for ISO Standards, Quality Auditing & Medical Device Regulations!

Comply Guru offers a growing portfolio of online, virtual & blended training courses on various ISO Standards, Quality Auditing & Medical Device Regulations to enable its Learners to get the knowledge and skills they need from home, work or anywhere!

Watch Video

This online, interactive course will provide a comprehensive introduction to the U.S Quality Systems Regulation (21 CFR 820).

Who Should Attend?

This course would be targeted at:

  • Quality Engineers
  • Internal Auditors
  • Quality Managers
  • Regulatory Professionals

Course Certification

This course is certified by Comply Guru. Successful completion will entitle each Learner to receive a digital Certificate of Completion.

Assessment Methodology

In order to successfully complete this online course, each Learner will need to:

  • Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

  • Course Access for 90-days
  • Phone & Email Support (Virtual Instructor)
  • The following topics are covered on this course:

    • An overview of FDA and intention of 21 CFR Part 820
    • Expectations and up-to-date requirements of 21 CFR Part 820
    • A working knowledge in application of the requirements
    • An explanation of each section of 21 CFR Part 820 and interpretation with respect to combination products

    E-Learning System Requirements

    The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS)  may be impacted, restricted and may not perform well.

    Recommended Operating Systems

    Windows 7/10, Mac OSX Sierra, iPad IOS10

    Mobile Devices

    Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

    Internet Speed

    We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

    Recommended Internet Browsers

    • Google Chrome 32 bit version 50 or later
    • Safari 10 or later
    Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is not recommended as its not compatible with the LMS and the course functionality will not work properly.

    Recommended Settings

    We recommend that the following settings are enabled:
    • Cookies
    • Pop-ups (in both Internet Browser and security software)
    • JavaScript
    • Plugins
    • Latest Version of Adobe Flash Player
    • Latest Version of Adobe Acrobat Reader
    To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

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