Request this Course
Submit this form to request this course to be scheduled.
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
Portability
This course may be taught at any location.
Level: Advanced
Lecture HoursLab HoursTotal
Instructor Pool
Tim Tice
Related Information
Video
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top... more
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top... more
eLearning
In this eLearning module you will learn about the federal and international regulations that... more
In this eLearning module you will learn about the federal and international regulations that... more
eLearning
This eLearning module will give you an understanding of the process used to develop drugs and why... more
This eLearning module will give you an understanding of the process used to develop drugs and why... more
Video
Capstone Center in Raleigh is BioNetwork's premiere worker training facility. At Capstone,... more
Capstone Center in Raleigh is BioNetwork's premiere worker training facility. At Capstone,... more
- 1 of 6
- >