21CFR820
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21 CFR 820 Essential Elements
By SkillsPlus International Inc.

This product has been discontinued.

If you need to provide new employees with an overview of 21 CFR 820, or if you need to provide your team with a refresher, take a closer look at this course. Numerous opportunities for students to challenge their knowledge and retention of information, keeps students engaged. 

This course was designed for affordability, and a quick teaching time which fits into most site's training schedules.

21 CFR 820: Essential Elements  - This program reviews 21 CFR 820 from inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing while getting a glimpse of medical device production techniques.

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  Time   Movie Interactive LMS
66 Min   $300 $325 $350

Course Description

Objectives

1. Identity common observations relating to documentation practices.
2. State data entry practices for paper-based and electronic records.
3. State the acceptable method for correcting documentation errors.
4. List unacceptable documentation practices.
5. Explain rounding rules.
6. State electronic record access controls.
7. Explain record protection and retention requirements. And Much More!

Topics
1. Common documentation practices deviations and observations.
2. Practices for entering information into paper-based records.
3. Acceptable methods for correcting paper-based documentation errors.
4. Unacceptable and prohibited documentation behaviors.
5. Rounding rules.
6. Paper and electronic record formats.
7. Electronic record access and security controls.
8. Record protection requirements.
Formats
1. Interactive CBT accessed from a CD or company intranet.
2. Learning Management System (LMS) plug-in.
3. CBT Flash movie without interactivity.

Features
1. Unlimited use at your plant site.
2. Global licensing options available.
3. No license renewal after original purchase.
4. Actual scenes from inside production facilities.
5. Ten practice quizzes throughout the program.

 

Features
1. Unlimited use at your plant site.
2. Global licensing options available.
3. No license renewal after original purchase.
4. Actual scenes from inside production facilities.
5. Ten practice quizzes throughout the program.
6. Final exam as a part of the program or LMS quiz module.
7. Reproducible student handout and paper quiz, if desired.

 

Benefits
1. All the development has been done for you.
2. Quickly addresses content in 40-minutes of viewing.
3. Ready-made CAPA response for documentation deviations.
4. Cost effective for all company and site sizes.
5. Sustainable CGMP documentation compliance.

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Questions? Just contact  us and we'll reply promptly:  415.948.5220 |  skillsplus@aol.com   

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