Study-Unit Description

Study-Unit Description


CODE SCI5509

 
TITLE QA and QMS: The Role and Professional Duties of the QP

 
UM LEVEL 05 - Postgraduate Modular Diploma or Degree Course

 
MQF LEVEL 7

 
ECTS CREDITS 6

 
DEPARTMENT Faculty of Science

 
DESCRIPTION This module describes the establishment and implementation of effective quality management systems required in the manufacture of medicinal products. The professional responsibilities of Qualified Persons (QPs) in ensuring that medicinal products are manufactured in accordance with their Marketing Authorisation and with Good Manufacturing Practice are also dealt with.

 
STUDY-UNIT TYPE Lecture

 
METHOD OF ASSESSMENT
Assessment Component/s Sept. Asst Session Weighting
Examination Yes 100%

 
LECTURER/S Dustin Balzan
Mario Barbara
Mario Sciberras
Lara Maria Trapani

 

 
The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints.
Units not attracting a sufficient number of registrations may be withdrawn without notice.
It should be noted that all the information in the description above applies to study-units available during the academic year 2024/5. It may be subject to change in subsequent years.

https://www.um.edu.mt/course/studyunit