Validation, Compliance and Quality (VCQ)

This certificate is designed for individuals who work or aspire to work in validation, compliance, or quality functions in industries driven by Good Manufacturing Practices (GMP). Students learn approaches to process validation, qualification of equipment, utilities, facilities, analytical methods, cleaning validation, etc., as well as quality related concepts and methods, and regulatory compliance issues in the global environment.

Validation, Compliance and Quality (VCQ) Requirements

Required Courses:

PME 540Validation in Life Sciences Manufacturing

3

PME 560Quality in Life Sciences Manufacturing

3

PME 602Statistical Methods in Life Sciences Industries

3

Plus one course from the following:

PME 541Validation of Computerized Systems

3

PME 542Global Regulation and Compliance in Life Science Industries

3