BioNetwork Capstone Certificate in Computer Validation

This certificate demonstrates the successful completion of a series of courses designed to provide the student with basic computer validation concepts and knowledge. Courses include interactive exercises and discussions that foster the application of learned content to typical biomanufacturing processes and the development of analytical and problem-solving skills.

Who should earn this certificate?

  • New and incumbent biomanufacturing operators, process technicians and entry-level professionals in the biotechnology, pharmaceutical and life science industries
  • Individuals retraining and transitioning from other industries into biomanufacturing jobs
  • College students and recent graduates of life sciences programs, including Agricultural Biotechnology, Agriculture, Biology, Biopharmaceutical Technology, Bioprocess Technology, Biotechnology, BioWork, Chemistry, Engineering, Laboratory Technician, Microbiology, Pharmaceutical Technology and Quality Assurance
  • Students who have earned or are pursuing a BioWork Certificate to enhance their job-related skills

Course requirements:

SEF-79524
Elements of CGMP Practices in Biomanufacturing Processes
16 hours
SEF-165CL
Fundamentals of Validation
8 hours
SEF-79754
Validation Documentation
8 hours
SEF-79534
Introduction to Computer Validation
8 hours
SEF-79844
Computer Application Validation
16 hours

About BioNetwork Capstone Center

BioNetwork is an initiative of the North Carolina Community College System designed to promote the growth of life science industries, education and employment opportunities in North Carolina. The Capstone Center is hosted by Wake Tech Community College and located in the Golden LEAF Biomanufacturing Training and Education Center on North Carolina State University's Centennial Campus in Raleigh. Facilities include a certified cleanroom suite and state-of-the-art laboratories. Courses are led by faculty with industry expertise, allowing a unique and exceptional training opportunity.  Experientially oriented courses provide an array of critical hands-on experiences and problem-solving skills necessary for working within a cGMP-focused environment.

Course details and registration information

For questions about the certificate or these courses, email [email protected].

Computer Application ValidationSEF-79844
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 se...
Elements of Current Good Manufacturing Practices in Biomanufacturing ProcessesSEF-79524
This course focuses on the application of current good manufacturing practices (cGMP) in the production of biopharmaceuticals. An overview of select topics will be covered from current regulations found in sections 210/211 of Title 21 of the Code of Federal Regulations (CFR...
Fundamentals of ValidationSEF-165CL
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation.
Introduction to Computer ValidationSEF-79534
This course provides 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...
Validation DocumentationSEF-79754
Learn the fundamental principles of validation documentation, including different types of documentation, the purpose of each, how they are utilized to ensure compliance, and how to utilize basic engineering documentation in support of qualification. Find out about the tools...
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