Course Details

Course Details
Course No. : 1917011575
Course Name : Pharmaceutical Quality Control and Regulatory Affairs
Prerequisite : 131701471 م
Credit  : 3
Theory credit : 3
Practical Credit : 0
Course Discription : This course investigates the current international guidelines and regulatory affairs related to the quality, safety, and efficacy of pharmaceutical dosage forms. It reviews the different guidelines related to the common technical document, test procedures and acceptance criteria for new drug substances and new drug products, Impurities in new drug substances and drug products, stability testing of new drug substances and products, Good Manufacturing Practices, Scale-Up and Postapproval Changes (SUPAC) Regulations, validation of analytical procedures, product development, Quality by Design and quality risk management, and investigation of bioequivalence studies.
Syllabus : Download
The Course offering during the First Semester-2025/2026
Section NOTheory SectionTeacherTime & Location
10 DR SHOROOQ MOHAMMAD ISSA ABUKHAMEES 08,30 - 10,00 ح ث / المادة تدرس بشكل مدمج في مبنى كلية العلوم الصيدلانية صيدلة 209 / على منصة(مايكروسوفت teams)
20 DR SHOROOQ MOHAMMAD ISSA ABUKHAMEES 12,00 - 13,30 ح ث / المادة تدرس بشكل مدمج في / على منصة(مايكروسوفت teams)
30 DR AREEN SULAIMAN MOHAMMAD AL SHWEIAT 10,30 - 12,00 ن ر / المادة تدرس بشكل مدمج في مبنى كلية العلوم الصيدلانية صيدلة 209 / على منصة(مايكروسوفت teams)
40 DR AREEN SULAIMAN MOHAMMAD AL SHWEIAT 13,30 - 15,00 ن ر / المادة تدرس بشكل مدمج في / على منصة(مايكروسوفت teams)