Pharmaceutical Quality Assurance & Quality Control

This program train student the comprehensive knowledge and skills in the fields of pharmaceutical analysis, quality assurances, and regulatory affairs. Students learn how to work in a pharmaceutical laboratory, familiar with GMP, GLP and SOPs, USP and analytical monographs Learn the wet chemistry and variety of analytical instruments HPLC, UV-Vis, FT-IR, Dissolution, GC, TLC and microbiology, the instrument’s theoretical, software application, calculation, computerized integrators and troubleshooting techniques. after completing the quality control part, the student will have the ability to the analysis of pharmaceutical raw materials, in-process and finish products and conduct pharmaceutical research duty.

Quality assurance will bring to the students a wide range of knowledge of quality assurance guidance GMP, GLP, and ICH in all areas that impact drug quality. Students will gain knowledge about the quality system and proper documentation practices (GDPs), SOPs and principles of product complaints, product recall, returned goods, change control and CAPA. They will learn how to manage validation protocol, batch documents, and investigation reports and be familiar with facility audits. At the end of the course, students will manage GMP and quality-related issues as well as various regulatory requirements. The course will introduce to the student’s essential knowledge of regulatory affairs across a broad range of healthcare products including medical devices, pharmaceutical, biologics and combination products.