REGULATORY & COMPLIANCE 21CFR PART 11 Publication Date: January 2007
R E G U L A O T R Y&C O M P L I O A N C E21C F R P A R T11
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1. Cour Information
Transcript
Welcome to “Understanding Part 11”, 21 CFR Part 11 is the FDA’s regulation for electronic record keeping.
Before beginning, plea take a moment to read the cour details.
Click on the Cour Notes button to download a PDF version of the cour. The cour notes contain all the text associated with the cour, including objectives, transcripts, and progress checks.
Recommended Curriculum For This TA
This cour is part of the Regulatory and Compliance curriculum. Cours in this curriculum are as follows:
1.Biostatistics
2.Drug Safety and Adver Events
3.GCP I (Introduction to Good Clinical Practice)
4.GCP II (GCP in Practice)
5.GLP (Good Laboratory Practice)
一般过去时的用法6.GMP (Good Manufacturing Practice)
7.21 CFR Part 11
Cour Details
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Cour Length: Approximately 2 hours. Your time may vary bad on modem speed, prerequisite knowledge, and other factors.
Prerequisites: None.
Date Published: January 2007名车图片
2. Interface Tour
Introduction
It is important that you become familiar with all of the functionalities of this interface so that you can u it optimally to navigate through the cour and to access the glossary, help, transcripts and resources ctions. This lesson gives you a tour of the interface.
Transcript
Features of this interface include:
The title of the current cour.
The title of the current lesson.
女人的脚Cour contents menu:
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Click lesson titles to access individual lessons. The current lesson will be highlighted. Completed lessons will be indicated by a different color.
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哪种减肥茶效果好My Notes: Click the “My Notes” tab to access a notepad to take notes at any point in the cour. The notes can be saved by emailing them or printing them out. Clicking the “Contents” tab will bring you back to the cour contents menu.
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3.Cour Overview
In August 1997, the FDA gave the industry a t of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records.
This cour is divided into five ctions:
The first ction, OVERVIEW, discuss why Title 21 of Code of Federal Regulations Part 11, or “21 CFR Part 11” was developed, and the role Part 11 plays in the adherence to other ctions of 21 CFR.
The cond ction, SECURITY, explores the general concepts of curity in a Part 11 compliant system, and the various requirements that must be met for a system to remain cure.
The third ction, AUDIT TRAIL, explains when, why, and how an audit trail is generated in a Part 11 system.
The fourth ction, TRAINING, lists the training requirements that must be met to achieve Part 11 compliance.
吊篮安装规范The final ction, PART 11 SYSTEMS, has been written for a Part 11 system administrator, and for tho who will be purchasing Part 11 systems and software.
R E G U L A O T R Y&C O M P L I O A N C E21C F R P A R T11
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4. OVERVIEW: Objectives
Introduction
“Part 11”, or Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11), is the t of rules and regulations t by the FDA governing electronic signatures and electronic records. Transcript
The are the objectives for this ction:唱得响亮
•Describe how the need for regulations with electronic records led to the creation of Part 11
•Identify the Part 11 regulations and their scope蜀道难李白原文
•Explain how Part 11 relates to other ctions of 21 CFR
•Describe why Part 11 compliance makes both legal and business n
•Explain the FDA trickle down theory of regulation
