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Tuesday, June 27, 2017
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Electronic Signatures & Records – 21 CFR Part 11 (ESR01)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: Electronic Signatures & Records – 21 CFR Part 11
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

The Food and Drug Administration established a set of rules for electronic signatures and electronic records back in 1997. The Electronic Signatures & Records- 21 CFR Part 11 Course is designed to explain why these regulations were developed, and the roles they play in accordance to other sections of 21 CFR. Students will have the chance to explore the general concepts of security in a Part 11 compliant system. Course completion requirements include passing an online, multiple-choice final assessment.

Benefits of Getting Certified at dinaris.org

For over two decades, dinaris.org has been providing comprehensive and flexible online training solutions for thousands of organizations across the pharmaceutical, healthcare, and biotechnology industries. Our eLearning solutions make it extremely convenient for professionals to upgrade their skills within a flexible schedule, and without having to allocate time to conduct or attend live training programs.

Each course is designed to engage students via an active learning process with tools such as live and recorded seminars, online books, high quality animations, and more. You can rest assured that we cater to both small-scale and large-scale training requests as well.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Electronic Signatures & Records – 21 CFR Part 11 Course is Found in the Following Professional Certification Program(s):


Electronic Signatures & Records Professional Certification Program: The Electronic Signatures & Records Professional Certification Program covers six areas of training, including compliance for electronic medical records, auditing for Part 11 compliance, proper procedures to pr … Learn more

COURSE OUTLINE:


INTRODUCTION
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

COURSE OBJECTIVES:


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.

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For more information on the dinaris.org’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 111-1111, or email Support@BioPharmaInstitute.com.

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