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2021 NFPA 70E for Supervisors and Managers
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Attach a Cloud Document to an Email
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Formatting Text
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fun at work
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Gatekeeper
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generation x
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Get Help in Microsoft Access
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GMP
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GoblinTools
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Grouping Information
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GROW Model
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Head
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Headers and Footers
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Health
4599 Courses
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1559 Courses
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HR
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Identify Components of a Personal Computer
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IE 11
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Inclusion
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India
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Insert
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Inserting a Table
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Insights Task Panel
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Install an App
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Interact with Windows Store Apps
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Internet Explorer
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Internet Explorer 11
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Interpersonal
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Interpersonal Skills
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Intersectionality
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Introduction
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inventory control
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Invisible Disabilities
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IP Networks
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know it all customers
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KPI
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Lean
12253 Courses
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Learn Concepts
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live chat
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Loading Dock
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Lock Out & Tag Out
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Lock Out & Tag Out
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Lock Out and Tag Out
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Lock Out Tag Out
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lockout tagout
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Lockout/Tagout
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Mail Merge
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Manage Folders with the File Explorer
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Manage your Inbox Using Clutter
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Manage Your Mailbox
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1717 Courses
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Management: Mentoring and Coaching
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Management: Safety
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Managers
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Managing Activities by Using Tasks
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Managing an Excel Workbook
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Managing Your Mailbox
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3094 Courses
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Materials Handling
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Materials Labels
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medical personnel safety
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meditation
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meeting delays
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meetings
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Mentoring
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Micro-affirmations
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Micro-Aggression
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Microaggressions
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Microlearning
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Microsoft
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Microsoft Excel
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Microsoft Excel 2010
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Microsoft Office
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Microsoft Outlook 2013
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microsoft teams
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Microsoft Word
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Microsoft Word 2010
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mindfulness
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mission
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Mobile Workers
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Modify a Table
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Modify Text
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Modifying a Worksheet
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Modifying Messages
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Modifying Save Options
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Modifying Tables
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Modifying the Appearance of a Workbook
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Modifying the Design of a Form
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Motivation
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motor vehicle inspections
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Moving and Resizing Charts
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MRSA
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MSDS
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Multitask with Apps
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National Fire Protection Association (NFPA)
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Navigate and Select Text
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Navigate the Desktop
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Navigate the File Explorer
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Navigate the Records Bar
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Navigate the Start Screen
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Navigate the Touch Screen
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Navigate Through Mail
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negotiating
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Network
28 Courses
Network Introduction
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Network Operating System Functions
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Network Operating Systems Introduction
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Network Protocols
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Networking
1549 Courses
Neurodiversity in the workplave
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New Presentations and Templates
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NFPA
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NFPA 70E
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no excuses
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objections
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Occupational Skills
361 Courses
offering a solution
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Office
42 Courses
Office 2010
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Office Environments
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Office Safety
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onboarding
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Opening and Closing a Database
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Opening and Closing Access
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Opening and Closing PowerPoint
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operations management
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Operators
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order management
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order selectors
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Organization Change
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Organizational Values
52 Courses
organizational valuess
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Organizing Files
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Organizing Information with Tab Pages
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Organizing Messages in Outlook
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Organizing Report Information
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Organizing Worksheet and Table Data
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OSHA
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OSHA Construction
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OSHA Genera
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OSHA General
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OSHA: Construction
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outbound calling
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outbound calls
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Outlook
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Outlook 20016
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Outlook 2016
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overcoming procrastination
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Overview
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ownership
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Page Breaks
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Page Margins
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Pallet
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pallet truck safety
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pallet trucks
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Pandemic
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pandemic awareness
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Parameter Queries
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Patient
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Patient Safety
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pdca
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Pedestrians
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Personal Fall Arrest System
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PivotCharts
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PivotTables
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pomodoro technique
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Positive response
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powered pallet jacks
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PowerPoint
9 Courses
PowerPoint 2010
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PowerPoint 2013
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PPE
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preferred pronouns
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Presentations
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Presenting Data Using Charts
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Preventing Injuries Above Ground
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Preventing Injuries Below Ground
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Prevention
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Print a Document
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Print an Email Message
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Printing Data in Columns
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Printing Excel Workbooks
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Problem Solving
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process
1531 Courses
procurement
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product marketing
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Productivity
7701 Courses
Professional Environment
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professional handshake
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project manager
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project scheduling
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projects
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Psychological Safety
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Publishing Slides to a Slide Library
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Query Criteria
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racial identity
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Read and Respond to Emails
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reflective listening
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relax
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Renumber a List
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Replacing Data
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Research Tools
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39 Courses
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Respiratory Protection
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Restore a File through File History
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Restricting Data Entry in Forms
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Retail
1533 Courses
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Retrieving Records Based on Input
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Reuse Formulas and Functions
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The GAMP Approach to 21 CFR Part 11 Compliance

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$ 199 .00
  • Description
  • Objectives
  • Reviews

The GAMP Approach to 21 CFR Part 11 Compliance Course

 

 

 

This GAMP approach to 21 CFR Part 11 compliance course offers a comprehensive overview of the regulation's requirements for electronic systems and provides steps your organization can follow to comply with them to avoid negative audit findings.

 

This course also provides an exhaustive understanding of the purpose of 21 CFR Part 11. We believe the 'why' is as important as the 'how' when it comes to Part 11 compliance.

 

As the FDA has very specific requirements as to what should be included to ensure that data captured electronically is accurate and precise, you will find the prescriptive nature of this course appealing to your QA and Regulatory Affairs departments. Lastly, this 21 CFR Part 11 course provides a detailed review of current FDA interpretations and lists the various requirements for 21 CFR Part 11 compliance.

 

21 CFR Part 11 Applicability:

 

21 CFR Part 11 regulates the use of electronic records and electronic signatures required by governing manufacturing processes in FDA regulated industry.

 

21 CFR Part 11 applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of FDA regulated products by firms which choose to use electronic records or signatures. This course identifies a few practical examples of 21 CFR Part 11 compliance. Therefore, this course will be valuable for all those professionals who use computer systems to perform their job functions. 

 

Subjects such as 21 CFR Part 11 compliance are multi-faceted and complex and can be better understood after going through this course. This course describes GAMP Records and the Data Integrity Guide and provides possible application of the risk management principle.

 

Course Objectives:

 

  • Explain the purpose of 21 CFR Part 11 compliance.
  • Recognize the current FDA interpretations.
  • List the various requirements for 21 CFR Part 11 compliance.
  • Identify a few practical examples of 21 CFR Part 11 compliance.
  • Describe GAMP Records and the Data Integrity Guide.
  • Identify a possible application of the risk management principle.

 

 

Objectives

By the end of this course you will be able to:

I. Explain the purpose of 21 CFR Part 11 compliance.

II. Recognize the current FDA interpretations.

III. List the various requirements for 21 CFR Part 11 compliance.

IV. Identify a few practical examples of 21 CFR Part 11 compliance.

V. Describe GAMP records and the Data Integrity Guide.

VI. Identify a possible application of the risk management principle.

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