Introduction to Computer Validation

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. Also covered are major areas subject to regulatory inspections and audit by the FDA and other international agencies. Samples of assessment tools are provided.

Audience

This course is designed for individuals seeking an understanding of computer system validations and/or professionals in the biotechnology industry with experience in Production and/or Quality Management seeking to apply these concepts at work.

Topics Include

This 1 day, 8 hour course covers the following topics:

  • Regulations and Guidance Related to Computer Systems
  • Quality Management Systems
  • Computerized System Life Cycle Phase
  • Validation Test Development
  • Types of Qualification (DQ, IQ, OQ, PQ)
  • Documentation Requirements/GMPs
  • 21 CFRs
  • Master Plans
  • Standard Operating Procedures (SOPs)
  • Contents of Validation Reports

Learning Objectives

Upon successful completion, participants will be able to:

  • Describe the regulatory requirements for computer validation
  • Identify criteria for determining system validation
  • Explain the major functions to test during validation
  • Differentiate key components and phases of computer validation
Introduction to Computer Validation

Colleges listed here when available.

Request this Course

Level: Advanced

Lecture HoursLab or Activity HoursTotal

Delivery Options

Face-to-Face
Delivered in-person in a classroom or lab setting.
Related
Batch Documents
eLearning
In this interactive exercise, you will learn the importance of batch documents by reviewing the... more
BioCertification Boot Camp
Course
All students who complete the BioWork Certificate Program successfully are eligible to take the... more
Biomanufacturing Bootcamp
Course
This course allows participants to experience biopharmaceutical manufacturing through lectures and... more
cGMP Basics
eLearning
Lesson 1: Introduction to Current Good Manufacturing Practices, introduces the fundamentals of cGMP... more
  •  
  • 1 of 7
  • >