Introduction to Computer Validation

This course may be taught at any location.

Request this Course

Request this Course

Submit this form to request this course to be scheduled.

2 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Introduction to Computer Validation
Level: Advanced
Lecture Hours: 4.00
Lab Hours: 4.00
Total Contact Hours: 8.00

Description

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.

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

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.

Current Courses
View All
October
2
Elements of Current Good Manufacturing Practices (CGMP) for the Food, Beverage, and Natural Products Industries
This course will provide an overview of current Food and Drug Administration (FDA) CGMP regulations and guidance for food, beverage, dietary supplements, and cosmetics businesses. These FDA regulations affect companies involved in the manufacturing, packaging, labeling, and holding of products
October
17
Introductory HACCP
Developing or following a Hazard Analysis Critical Control Point (HACCP) plan can be daunting. In this course, learn how HACCP systems work and your role in regulatory compliance. A series of interactive class exercises helps you nail down the step-by-step process of developing and implementing an
November
7
FSPCA Preventive Controls For Human Foods: Preventive Controls Qualified Individual (PCQI)
Are you looking to become a Preventive Controls Qualified Individual (PCQI)? Completing our course is one way to achieve that goal. Developed by the Food Safety Preventive Controls Alliance (FSPCA), this course is the standardized curriculum recognized by FDA. Regulations for the Current Good
  •  
  • 1 of 4
  • >
Current Courses
View All
August
27
Computer Application Validation
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,
September
14
Segment Two - Seafood HACCP (AFDO Accredited)
Advance your food safety career with a certificate from the Association of Food and Drug Officials (AFDO). This certificate provides evidence that you have met the FDA Seafood HACCP training requirement. You can earn your certification by attending our FDA-recognized course, Seafood HACCP Segment
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 4
  • >
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.
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.
  •  
  • 1 of 3
  • >
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.
Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP)
You’re the newest member of the Quality Assurance department at CATT - the Center for the Advancement of Toast Technology. Your mission is to audit the company and determine if it’s SOPs, notebooks, equipment, personnel, reagent labels, and test animals are GLP compliant.
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
  •  
  • 1 of 3
  • >
eLearning
View All
Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP)
You’re the newest member of the Quality Assurance department at CATT - the Center for the Advancement of Toast Technology. Your mission is to audit the company and determine if it’s SOPs, notebooks, equipment, personnel, reagent labels, and test animals are GLP compliant.
Good Manufacturing Practice (GMP) Requirements
Good Manufacturing Practice (GMP) Requirements
GMPs help ensure the quality, safety, and efficacy of a product. You'll explore Good Manufacturing Practices as you work through several interactive scenarios in a virtual manufacturing facility.
Deliberate Documentation
Deliberate Documentation
Hi, I’m Mia! Let's discover how documentation is kept and used in a regulated manufacturing environment. So why is documentation important? Well, think about this situation. You’re preparing a solution that's used as a component in several products manufactured by your company. Many people count on
  •  
  • 1 of 3
  • >
Videos
View All
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
Golden LEAF Biomanufacturing Training and Education Center
Golden LEAF BTEC: Knowledge in Action
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top-tier learning organizations: NC State and BioNetwork. Through this unique partnership, learners from a wide range of backgrounds can find the right educational program to meet their career goals, and
NC Life Science
NC Life Science
This video surveys examples of life science-related training provided by NC Community Colleges for local employers, and how that training supports North Carolina's position as a leading life science industry hub. Representatives of tissue-engineering, clinical research, and pharmaceutical
  •  
  • 1 of 4
  • >
Videos
View All
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
Golden LEAF Biomanufacturing Training and Education Center
Golden LEAF BTEC: Knowledge in Action
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top-tier learning organizations: NC State and BioNetwork. Through this unique partnership, learners from a wide range of backgrounds can find the right educational program to meet their career goals, and
Bioprocessing Part 3: Purification
Bioprocessing Part 3: Purification
This video is the third in a series of three videos depicting the major stages of industrial-scale fermentation: fermentation, separation/recovery, and purification. This program describes the process by which a biological product—in this case, a pure, concentrated solution of Green Fluorescent
  •  
  • 1 of 4
  • >
Videos
View All
Lab Safety Lesson 1: Proper Dress and PPE
Lab Safety Lesson 1: Proper Dress and PPE
The lab environment is hazardous by nature. The actual risk is largely determined by you and those working with you. It's your responsibility to know and follow the rules and be able to recognize potential safety hazards. The first consideration is proper dress. What you wear in the lab can help
Aseptic Gowning for the Cleanroom
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
  •  
  • 1 of 4
  • >
Activities
View All
Belly Busters
Belly Busters
Convert your students into a pharmaceutical research and development team! In this activity students use 21st century skills and science methodologies to develop a budget friendly antacid that provides patient relief without uncomfortable side effects. They'll learn how to not break the bank or
GMO Detective
GMO Detective
How do scientists prove whether or not foods contain GMOs? Using real life techniques, students will perform several analyses to detect whether food samples have been genetically modified.
Quality Matters
Quality Matters
Quality assurance is a strict and stringent industry process that utilizes chemical and physical properties to ensure the end product not only meets a company's standards but also those regulated by the FDA. Students will learn about this critical aspect of modern industry by conducting a battery
Activities
View All
Belly Busters
Belly Busters
Convert your students into a pharmaceutical research and development team! In this activity students use 21st century skills and science methodologies to develop a budget friendly antacid that provides patient relief without uncomfortable side effects. They'll learn how to not break the bank or
GMO Detective
GMO Detective
How do scientists prove whether or not foods contain GMOs? Using real life techniques, students will perform several analyses to detect whether food samples have been genetically modified.
Quality Matters
Quality Matters
Quality assurance is a strict and stringent industry process that utilizes chemical and physical properties to ensure the end product not only meets a company's standards but also those regulated by the FDA. Students will learn about this critical aspect of modern industry by conducting a battery
Activities
View All
GMO Detective
GMO Detective
How do scientists prove whether or not foods contain GMOs? Using real life techniques, students will perform several analyses to detect whether food samples have been genetically modified.
Quality Matters
Quality Matters
Quality assurance is a strict and stringent industry process that utilizes chemical and physical properties to ensure the end product not only meets a company's standards but also those regulated by the FDA. Students will learn about this critical aspect of modern industry by conducting a battery
Belly Busters
Belly Busters
Convert your students into a pharmaceutical research and development team! In this activity students use 21st century skills and science methodologies to develop a budget friendly antacid that provides patient relief without uncomfortable side effects. They'll learn how to not break the bank or