Computer Application Validation

This course may be taught at any location.

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Computer Application Validation
Level: Advanced
Lecture Hours: 16.00
Lab Hours: 0.00
Total Contact Hours: 16.00
Currently Offered
Computer Application Validation - Class begins August 27, 2018

Description

Interactively learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems security, data integrity, backup and recovery. Hands-on exercises allow students to use validation principles through assessments to determine the level of validation required, writing validation plans, protocols, executing protocols, and analyzing results. Case studies and simulated validation deviations allow participants to experience real-life situations while honing problem-solving skills.

Topics Include

This 2 day,16 hour course, covers the following topics:

  • Types of Computer Application Validation
  • GMPs and Regulatory Requirements
  • Industry Guidance Documents and Documentation requirements
  • Risk Assessments and Determining what to test
  • Creating validation documentation
  • Handling discrepancies or deviations during testing

Learning Objectives

Upon successful completion participants will be able to:

  • Understand regulatory requirements related to information systems
  • Assess the levels of validation needed for computer system applications
  • Determine key functions within computer systems
  • Demonstrate proficiency in handling validation deviations
  • Prepare and respond to requirements of validation auditors

Audience

This course is designed for individuals seeking industry training related to validation work done for computer system applications and personnel responsible for implementing and using regulated computer systems in the biotechnology and biopharmaceutical sector.

Current Courses
View All
July
25
Introduction to Computer Validation
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements
September
24
Validation of Automated Equipment & Process Control Systems
Learn the process for validation of automated equipment and process control systems typically found in the biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities including discussion of case studies and hands-on development of documentation
July
10
Sterilization and Controlled Temperature Environment Validation
This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) Systems, by providing a thorough understanding of
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  • 1 of 2
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Current Courses
View All
July
10
Sterilization and Controlled Temperature Environment Validation
This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) Systems, by providing a thorough understanding of
July
25
Introduction to Computer Validation
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements
September
24
Validation of Automated Equipment & Process Control Systems
Learn the process for validation of automated equipment and process control systems typically found in the biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities including discussion of case studies and hands-on development of documentation
  •  
  • 1 of 2
  • >
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Validation Fundamentals
Validation Fundamentals
In this short eLearning course, you'll learn the fundamentals of process and equipment validation in the manufacture of pharmaceuticals. Explore the history of validation, what validation means, what must be validated, and when it must be validated.
eLearning
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Drug Development Overview
Drug Development Overview
This eLearning module will give you an understanding of the process used to develop drugs and why it costs so much to bring a new drug to your pharmacy.
Regulations and Guidance
Regulations and Guidance
In this eLearning module you will learn about the federal and international regulations that protect human participants in research studies. You will also get to be a drug company auditor, reviewing research studies at clinics to see if the staff are following the regulations, and looking for
Validation Fundamentals
Validation Fundamentals
In this short eLearning course, you'll learn the fundamentals of process and equipment validation in the manufacture of pharmaceuticals. Explore the history of validation, what validation means, what must be validated, and when it must be validated.
eLearning
View All
Drug Development Overview
Drug Development Overview
This eLearning module will give you an understanding of the process used to develop drugs and why it costs so much to bring a new drug to your pharmacy.
Validation Fundamentals
Validation Fundamentals
In this short eLearning course, you'll learn the fundamentals of process and equipment validation in the manufacture of pharmaceuticals. Explore the history of validation, what validation means, what must be validated, and when it must be validated.
Regulations and Guidance
Regulations and Guidance
In this eLearning module you will learn about the federal and international regulations that protect human participants in research studies. You will also get to be a drug company auditor, reviewing research studies at clinics to see if the staff are following the regulations, and looking for
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