ATE Central

Course in a Box: Quality Regulations and Standards


Program Description
Bio-Link offers a number of Course-in-a-Box resources. Each course is a collection of resources for instructors to adapt and introduce into a new course. The collections of resources have been compiled and contributed by instructors of Bio-Link programs. Resources can include course descriptions, student outcomes, schedules, reading assignments, laboratory exercise, lecture materials, homework, classroom activities, exams, and videos.

Course Description
This Quality Regulations and Standards Course-in-a-Box includes a 6-page outline of quality/regulatory topics. Each topic includes additional important information. Topics include Overview of the Biotechnology Industry; Quality Philosophies of Yesterday and Today; Reducing Variability; Documentation; Overview of the Regulation of Medical Products in the U.S.; Overview of manufacturing processes; Other Products; The Regulation of Drugs, Particularly Biopharmaceuticals; Medical Devices, Particularly Diagnostics; Combination Products; Quality in the Laboratory Environment; International Issues; International Organization for Standardization (ISO); Specialized Documents for Biotechnology; and Extra Topics to Business.

Additional related instructional materials are available from Bio-Link and include classroom activities, PowerPoint presentations, exams, and learning modules.

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