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SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
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Introduction
ICH Q10 Pharmaceutical Quality System
Dr Solah
Guidelines: PICS GMP with 20 Annexes
Guidelines: PICS GMP Part 1
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
Guidelines: ICH Q9-R1 Quality Risk Management
Lecture Slides: Quality Risk Management
Example: Risk Assessment Evaluation Report Form
PPPT3282 Quality and Validation 3 (process validation) (2)
Prof. Dr. Helal
QC and Good Lab Practice
Validation adn Verification
OOS
DR SITI HADIJAH
GOOD DOCUMENTATION PRACTICE (GDocP)
GDoc-References
OUTSOURCE ACTIVITIES & CONTRACT MFG
Product Quality Review
QUALITY MANAGEMENT -THRU PRODUCT LIFE CYCLE
Dr. Rushdi
Guidelines Related to PQM
Personnel & Premise
Computerised System
Quality & Validation 1 (Equipment)
Quality & Validation 2 (Utilities)
Assignment: Case Study 1, 2 & 3
Case Studies (1-3)
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All categories
Miscellaneous
CPS Supervisory Training
Session 2024/2025 Semester 1
AHMAD IBRAHIM KULLIYYAH OF LAWS
ALLIED HEALTH SCIENCE
ARCHITECTURE & ENVIRONMENTAL DESIGN
ARTS PROGRAMME
CO-CURRICULAR ACTIVITY CENTRE
CREDITED CO-CURRICULAR CENTRE
DENTISTRY
ECONOMICS AND MANAGEMENT SCIENCES
EDUCATION
ENGINEERING
INFORMATION & COMMUNICATION TECHNOLOGY
INTERNATIONAL INSTITUTE FOR HALAL RESEARCH AND TRAINING
INTERNATIONAL INSTITUTE OF ISLAMIC THOUGHT AND CIVILIZATION
ISLAMIC BANKING AND FINANCE
ISLAMIC REVEALED KNOWLEDGE AND HUMAN SCIENCES
LANGUAGES
LANGUAGES & PRE-UNIVERSITY ACADEMIC DEVELOPMENT
LANGUAGES AND MANAGEMENT
MEDICINE
NURSING
PHARMACY
PLANETARY SURVIVAL FOR SUSTAINABLE WELL-BEING
SCIENCE
SCIENCES PROGRAMME
SEJAHTERA CENTRE FOR SUSTAINABILITY AND HUMANITY
Session 2024/2025 Semester 2
AHMAD IBRAHIM KULLIYYAH OF LAWS
ALLIED HEALTH SCIENCE
ARCHITECTURE & ENVIRONMENTAL DESIGN
ARTS PROGRAMME
CREDITED CO-CURRICULAR CENTRE
DENTISTRY
ECONOMICS AND MANAGEMENT SCIENCES
EDUCATION
ENGINEERING
INFORMATION & COMMUNICATION TECHNOLOGY
INTERNATIONAL INSTITUTE FOR HALAL RESEARCH AND TRAINING
INTERNATIONAL INSTITUTE OF ISLAMIC THOUGHT AND CIVILIZATION
ISLAMIC BANKING AND FINANCE
ISLAMIC REVEALED KNOWLEDGE AND HUMAN SCIENCES
LANGUAGES
LANGUAGES & PRE-UNIVERSITY ACADEMIC DEVELOPMENT
LANGUAGES AND MANAGEMENT
MEDICINE
NURSING
PHARMACY
PLANETARY SURVIVAL FOR SUSTAINABLE WELL-BEING
SCIENCE
SCIENCES PROGRAMME
SEJAHTERA CENTRE FOR SUSTAINABILITY AND HUMANITY
SUSTAINABLE TOURISM AND CONTEMPORARY LANGUAGES
Session 2024/2025 Semester 3
ARTS PROGRAMME
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SCIENCES PROGRAMME
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Summary
Course info
SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
Skill Level
:
Beginner
