iTa'LeEm
SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
0%
Previous
Course data
عام
Announcements
Course Outline
Dr. Rushdi
Course Briefing
Introduction to PQM
Guidelines Related to PQM
Personnel & Premise
Computerised System
Quality & Validation 1: Equipment
Quality & Validation 2: Utilities
Handling Deviations
CAPA
Supplementary Reading: How to Manage CAPA?
PQM from Islamic View
Dr. Helal
QC and Good laboratory Practice
Validation and verification in QC
OOS - Out of Specification
Dr. Solah
Guidelines: PICS GMP Guide with Annexes
Lecture slides: Production According to GMP
Lecture slides:Quality and Validation 3 (Process Validation)
Lecture slides: Quality and Validation 4 (Cleaning Validation)
Additional Reading: Cleaning Validation Maximum Allowable Concentration
Lecture slides:Quality Risk Management
Guidelines: ICH Q9-R1 Quality Risk Management
Form: Risk Assessment Evaluation & Report Form
Case Studies
Case Studies Assignment
Rubrics for Written Report
Rubrics for Video Presentation
Recommended Outline for Written Report
What is “(b)(4)” ?
Submission of Case Study 1 (Written Report)
Submission of Case Study 1 (5-min video)
Submission of Case Study 2 (Written Report)
Submission of Case Study 2 (5-min video)
Submission of Case Study 3 (Written Report)
Submission of Case Study 3 (5-min Video)
Dr. Siti Hadijah
OUTSOURCE ACTIVITIES & CONTRACT MFG
GDocP
Next
iTa'LeEm
واجهة جانبية
2022/2023 Academic Session
2021/2022 Academic Session
2020/2021 Academic Session
2019/2020 Academic Session
العربية (ar)
Bahasa Melayu (ms)
English (en)
العربية (ar)
تسجيل الدخول
Course Navigation
PPPT 3282 SEM2
Site Navigation
الصفحة الرئيسية
تجاوز إلى المحتوى الرئيسي
معلومات المقرر الدراسي
الصفحة الرئيسية
المقررات الدراسية
Session 2023/2024 Semester 2
PHARMACY
PPPT 3282 SEM2
الملخص
SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
Instructor:
MOHD. RUSHDI BIN HJ. ABU BAKAR 4033
Instructor:
A.B.M. HELAL UDDIN 4478
Instructor:
SITI HADIJAH BINTI SHAMSUDIN 4916
Instructor:
MUHAMMAD SALAHUDDIN BIN HARIS @ HARITH 6657
Instructor:
Assoc. Prof. Dr. Haliza Katas
Skill Level
:
Beginner