Using careful reviews of requirements from ISO 9001:2000, ISO 13485 and QSR along with case studies and in-class activities, learn the fundamentals and principles of process validation. Focus is on the planning, specifications, and requirements necessary to meet ISO and FDA requirements for process validation. FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics." Process validation class discussions and team workshops also cover interpretation of process validation as described by the Global Harmonization Task Force and as required by FDA's Medical Device Quality System Regulation, ISO 9001, ISO 13485:2003.