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Timetable: Part 1: Regulatory Aspects of Pharmaceutical Manufacture

The document outlines a 5-week timetable for a course on the regulatory aspects of pharmaceutical manufacture. In week 1, lecturer Ai See will cover the pharmaceutical quality assurance system, good manufacturing practice, and quality control. In week 2, Ai See will discuss international regulations governing good manufacturing practice. For weeks 3 through 6, Dr. Kyle will cover compliance issues for pharmaceuticals including validation, equipment, premises, production, standard operating procedures, documentation, organization and personnel, and quality control. A quiz will be held in week 7.

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Nigel Kow
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58 views2 pages

Timetable: Part 1: Regulatory Aspects of Pharmaceutical Manufacture

The document outlines a 5-week timetable for a course on the regulatory aspects of pharmaceutical manufacture. In week 1, lecturer Ai See will cover the pharmaceutical quality assurance system, good manufacturing practice, and quality control. In week 2, Ai See will discuss international regulations governing good manufacturing practice. For weeks 3 through 6, Dr. Kyle will cover compliance issues for pharmaceuticals including validation, equipment, premises, production, standard operating procedures, documentation, organization and personnel, and quality control. A quiz will be held in week 7.

Uploaded by

Nigel Kow
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Timetable

Part 1: Regulatory Aspects of Pharmaceutical Manufacture


Week
1
(11 Jan - 15 Jan)

Lecturer
Ai See

2
(18 Jan 22 Jan)

Ai See

3
(25 Jan 29 Jan)

Ai See

4
(01 Feb 05 Feb)

Ai See

5
(08 Feb 12 Feb)

Dr. Kyle

Lecture Topic
Topic 1:
Pharmaceutical Quality
Assurance System (PQAS)
Lifecycle of a drug product
Principles and requirements
of PQAS
Good Manufacturing
Practice
Quality Control
Quality Risk Management
Corporate responsibility for
GMP compliance and cost
of non-compliance
Topic 2:
International Regulations
Governing GMP
Regulations for
pharmaceuticals
International Conference
on Harmonization
Comparison of the
regulations
Topic 3:
Compliance Issues for
Pharmaceuticals
Validation
Topic 3:
Compliance Issues for
Pharmaceuticals
Equipment
Premises
Production
Topic 3:
Compliance Issues for
Pharmaceuticals
Standard Operating
Procedures (SOP)
Documentation

Tutorial
No
tutorial

CN 4233R Good Manufacturing Practices in Pharmaceutical Industry


6
(15 Feb 19 Feb)

Dr. Kyle

Topic 3:
Compliance Issues for
Pharmaceuticals
Organisation and Personnel
Quality Control

Recess Week
(20 Feb 28 Feb)
7
(29 Feb 04 Mar)

Dr. Kyle &


Ai See

Quiz 1

No
tutorial

CN 4233R Good Manufacturing Practices in Pharmaceutical Industry

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