Pharmaceutical Technology & Quality Systems

Course Outline
This two-year Pharmaceutical Technology & Quality Systems distance learning programme is aimed at graduates who currently work within the pharmaceutical industry and wish to fulfil the EU educational requirements for Qualified Person (QP) status. Graduates who complete this course and have relevant work experience are eligible to apply to the Health Products Regulatory Authority (HPRA) or EU regulatory authority to register as a QP.

The course is not limited to aspiring QPs: it is designed to broaden your professional development and provide up-to-date assessments of the latest trends in the areas of pharmaceutical/biopharmaceutical development, manufacturing and quality. The individual modules provide knowledge and experience of benefit to all technical, quality, regulatory and managerial staff in the pharmaceutical industry.

Course Requirements Pathway 1

In Part I, you will take taught modules to the value of 60 credits, run over a minimum of 18 months. The taught modules incorporate a combination of online module notes, recorded material, webinars, workshops, online assessments and end of year written exams. Students must also attend the two workshops on campus each year, involving lectures, practical sessions, tutorials and industrial site visits.

In Part II, students complete a research project module to the value of 30 credits.

Modules (90 credits)

Part I

PF6200 Pharmaceutical Chemistry (10 credits)
PF6201 Pharmaceutical Dosage Form Design (5 credits)
PT6401 Pharmacology (5 credits)
PF6202 Pharmaceutical Manufacturing - API to Finished Product (5 credits)
PF6203 Pharmaceutical Microbiology and Sterile Manufacturing (5 credits)
PF6204 Biopharmaceutical Development of Investigational Medicinal Products (5 credits)
PF6205 Pharmaceutical Biotechnology (5 credits)
PF6206 Pharmaceutical Statistics and Process Control (5 credits)
PF6207 Pharmaceutical Plant and Process: From Design through Validation (5 credits)
PF6208 Quality Management Systems and Regulatory Affairs (5 credits)
PF6209 Role and Professional Duties of the Qualified Person (5 credits)

Part II
PF6210 Research Project — Pharmaceutical Technology and Quality Systems (30 credits)

The research project will be within the field of Pharmaceutical Technology and Quality Systems. Consideration will be given to your chosen project area but all project titles must be approved in advance by the course committee and supervised by a member of the academic staff at UCC.

Note: Taught modules are offered on a cyclical basis over alternative years.

Course Requirements (Pathway 2)
Students take 30 credits as follows:
PF6210 Research Project — Pharmaceutical Technology and Quality Systems (30 credits)

Please note: you will be required to provide additional information as part of the online application process for this programme. This will include the following:

Please download, complete, & upload this Company Reference Template.

Entry Requirements (Pathway 1): All candidates must be approved by the programme committee within the School of Pharmacy. Applicants may be short listed for interview.

a candidate must have obtained at least a Second Class Honours in a primary honours degree (NFQ, Level 8) in a relevant science discipline which has been approved by the programme committee (e.g. pharmacy, chemistry or the biological sciences);

candidates must be currently employed in a relevant pharmaceutical sector (ideally greater than two years experience) and for the duration of the programme;
consideration under Recognition of Prior Learning (RPL) may be given to other applicants with suitable equivalent professional qualifications and significant industrial experience (greater than 5 years relevant experience in the pharmaceutical industry).

Note: Candidates who successfully complete this programme and wish to become a QP must apply to the HPRA to become registered as a QP and should also note the following:

they must also have an appropriate primary degree that is considered by the HPRA to meet the specific requirements for primary qualifications listed in article 49 of 2001/83/EC (e.g. chemistry, pharmaceutical chemistry and technology, biology);

they must provide evidence to the Health Products Regulatory Authority (HPRA) that they ‘have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of testing and checking necessary to ensure the quality of medicinal products’.

Entry Requirements (Pathway 2) (In addition to the above):
The Programme Management Committee may permit graduates holding a Postgraduate Diploma (equivalent to NFQ Level 9 award) in Pharmaceutical Technology and Quality Systems from an appropriately accredited School of Pharmacy to enter a one year programme. To be considered for entry to this programme, candidates must have completed their Postgraduate Diploma no later than five years prior to the date of registration for this programme. All candidates must be approved by the programme committee within the School of Pharmacy. Applicants may be shortlisted for interview.

Please be advised that all Irish/EU applications will be reviewed after the closing date has passed regardless of the initial date of application.

Closing Date Rolling deadline. Open until all places have been filled. Early application is advised.

Assessment

Assessment consists of a mixture of continuous assessment and end-of-year written exams. Exams take place in April each year, with repeats in autumn if required.

Continuous assessments form part of each taught module and can be in various formats such as online MCQs, essays and interactive exercises on Canvas. The value of the continuous assessments varies for each module but can count for 20-50% of the overall mark.

2 years part-time.

Start Date: 11 September 2023

Skills and Careers Information
Although the course meets the educational requirements for registering as a QP, it is not only aspiring QPs who complete the course. Many of our graduates use the skills obtained in the course to develop their careers within other areas of the pharmaceutical industry.

Students from the EU can use this qualification to apply to your regulatory authority to register as a QP. Recently a number of our students from Malta graduated from this course and registered as QPs in Malta.