DOSAGE FORM DESIGN

(Elective course / Teaching hours per week: 3 / Assessment: final exam at the end of each term or September/ Credits: 3)

Teachers: 

D. M. Rekkas (Associate Professor)

Topics:

    • Quality of Conformance and Quality by Design (QbD)
    • Major contributions in developing the theory of Quality.
    • Introduction to the Process/System theories.
    • Regulatory requirements for Pharmaceutical Development.
    • ICHQ8 (Pharmaceutical Development).
    • ICHQQ9 (Quality Risk Management, QRM).
    • ICHQ10 (Pharmaceutical Quality System, PQS).
    • Continuous Process Verification.
    • Experimental Design (Design of Experiments, DoE).
    • Factorial and Mixture Designs- Examples.
    • Statistical Process Control Tools (SPC). 
    • Process Capability Indices.
    • Examples and Case studies