Gain a recognized and traceable certificate after completing the course :
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The idea that final testing of pharmaceutical products does anything with regards to ensuring quality has long been exposed as a lie. Quality has been defined in numerous ways, however, a definition that captures adequately what it means in the pharmaceutical industry is the fitness for use. This goal can only be achieved by building quality into the end product through every process in its actualization. This goes as far back as sourcing for good quality raw materials, subjecting systems and equipment to routine evaluations, and improving the manufacturing process while taking into consideration feedback from these evaluations and final consumers. This course introduces students to the concepts of the Quality Management System and Total Quality Management. You will also be introduced to the role of ICH guidelines in achieving quality the process way.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Pharmaceutical Quality
Lesson 2: Quality Management System (QMS)
Lesson 3: Total Quality Management (TQM)
Lesson 4: Quality Manual and Quality Policy
Lesson 5: Understanding Pharmaceutical Quality by Design
Lesson 6: ICH Guidelines