REGULATIONS AND GOOD MANUFACTURING PRACTICES

Catalog description

The course provides students with a broader overview of the basic concepts of current regulations applicable to Puerto Rico, including a review of OSHA, PROSHA, and EPA/EQB regulations, with a particular emphasis on FDA rules and regulations. The course will focus on Good Manufacturing Practices (GMP), quality, data integrity, safety, hazard analysis and critical control points, sanitary facilities, environmental protection, traceability, pest control, all appropriate control measures, claim cases, risks an d the basics of audit documentation, the 4583, and commercial impact in dollars and cents. The course will explore standards and procedures carried out under proper sanitary conditions for personal hygiene and human consumption products such as food and be verages, pharmaceuticals, and others. It also facilitates the development of competencies related to innovation, scientific reasoning, technology, communication, and information management using ethical principles.