Wake Tech offers a variety of non-degree, short classes and certificate training programs in biotechnology, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.
For those interested in earning a degree to work in the biotech industry, visit Wake Tech's Biotechnology Department.
Financial assistance available
Workforce Continuing Education offers financial assistance for many workforce training programs through the Propel program and other resources. Email [email protected] for more information.
Course details and registration information
- Understand the motivation and purpose of medical product validation.
- Understand the difference between "qualification" and "validation" practices.
- Be orientated and become familiar with requirements of the 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices" and EudraLex Vol. 4 Annex 15 "Qualification and Validation".
- Introduction: factors precipitating FDA’s validation concept and approach
- Foundational concepts and approaches established by FDA’s 1987 “Guideline on General Principles of Process Validation”
- Medial device validation - the “Design Control” approach
- The influence and impact of modern cGMPs on validation
- Validation principles updated by the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices”
- Compare and contrast the 011 FDA Guidance to Industry “Process Validation: General Principles and Practices” with the 2015 EudraLex Vol. 4 Annex 15 “Qualification and Validation” Guideline
- The regulatory basis for drug and medical device validation requirements
- Attendance 80% or above
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