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. 

This certificate is recommended for:

  • New and incumbent process, laboratory, and utility technicians and entry-level professionals in the biotechnology and medical device industries.
  • Individuals retraining and transitioning from other industries into biomanufacturing jobs.
  • College and community college students or graduates of programs in the life sciences, such as: 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 (BTEC) on the North Carolina State Centennial Campus in Raleigh, North Carolina. Our facilities include a certified cleanroom suite and state-of-the-art laboratories. Our courses are led by faculty with industry expertise, allowing us to provide 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.

Register for Certificate Courses

Click a course in the list below to register for an open section. 
For questions about the certificate or these classes please contact us at [email protected]. 

Fundamentals of ValidationSEF-165CL1 available classes
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation.
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...
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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