Source: https://www.biopharmainstitute.com/e-learning?PIDvalue=ESR01
Timestamp: 2018-12-11 05:18:55
Document Index: 416753512

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'ART 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Electronic Signatures & Records - 21 CFR Part 11 Online Training Course – BioPharma Institute
Electronic Signatures & Records – 21 CFR Part 11 (ESR01)
Catalog: Electronic Records.
Training Program: Electronic Signatures & Records – 21 CFR Part 11
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.
For over two decades, BioPharma Institute 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.
The Electronic Signatures & Records – 21 CFR Part 11 course is found in the following professional certification program(s):
5. The Need for Part 11
6. Electronic Records
7. Developer vs. User Requirements
9. General Concepts
11. Open and Closed Systems
14. General Concepts
15. Electronic Signatures
16. Objectives
18. Supporting Procedural Infrastructure
PART 11 SYSTEMS
19. Objectives
21. Security Issues
22. Compliance
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.
Electronic Signatures & Records – 21 CFR Part 11