Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.
Course Details & 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