PRINCIPLES OF INDUSTRIAL REGULATIONS AND VALIDATIONS

Catalog description

In this course the student acquires knowledge in Current Good Manufacturing Practices (cGMP's) and the series of international quality standards known as ISO 9000 to ISO 9004, ISO 10011, 10012, ISO 13485 and ISO 14000. It is including, validation to characterize processes, intermediate processes, and final products emphasizing cost - effective use while determining what levels of validation are required for the different phases of process development and improvement. Topics such as water system validation, cleaning validation, computerized systems validation, equipment validation, and current trends in process validation are discussed. Students will develop technological competencies that are required in the healthcare manufactur ing industry.