21 CFR Part 11 course

Duration: 1 Hour and 45 Minutes

Certificate of Completion:

Provided immediately upon successful completion.

21 CFR Part 11 Description: In August, 1997, the FDA gave the Industry the set of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of Code of Federal Regulations Part 11, or "21 CFR Part 11" was developed, the role Part 11 plays in the adherence to other sections of 21 CFR, and explores the general concepts of security in a Part 11 compliant system.

Accreditation: GeneEd designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.

GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.

In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.

21 CFR Part 11

OUTLINEINTRODUCTION

1. Course Information

2. Interface Tour

3. Course Overview

OVERVIEW

4. Objectives

5. The Need for Part 11

6. Electronic Records

7. Developer vs. User Requirements

SECURITY

8. Objectives

9. General Concepts

10. Passwords

11. Open and Closed Systems

12. Data Management

AUDIT TRAILS

13. Objectives

14. General Concepts

15. Electronic Signatures

TRAINING

16. Objectives

17. Training

18. Supporting Procedural Infrastructure

PART 11 SYSTEMS

19. Objectives

20. Validation

21. Security Issues

22. Compliance

CONCLUSION

23. Summary

OBJECTIVES: Students completing this course, 21 CFR Part 11, should be able to:

Describe how the need for regulations on electronic records led to the creation of Part 11.

Identify the Part 11 regulations and their scope.

Explain how Part 11 relates to other sections of 21 CFR. Describe why Part 11 compliance makes both legal and business sense.

Explain the FDA trickle-down theory of regulation. Identify the main areas of security concern and the implications of threats in these areas.

Explain how passwords are used to protect data and the importance of NOT sharing passwords.

About GeneEd's Online Training:

* GeneEd Online Training Courses are high-quality, Flash driven, learning tools including voiceovers and dynamically engaging graphic animations.

* This GeneEd Online Training Course is accessible for 90 days via the Internet, and a Certificate of Completion is accessible once requirements are filled.

* GeneEd Online Training Courses have an instructional design which encourages knowledge retention and long term recollection.

* GeneEd Online Training Courses are developed for healthcare professionals (nurses and doctors), clinical researchers, and for patient education.

* To access your GeneEd Online Training Course, your username, password and login URL will be provided to you shortly after ordering.

Unit 6 of 6 courses
Price: $275.00 / GBP181.50