Quality & Regulatory Practice in the Pharmaceutical Industry
Overview
An accredited QQI Level 9 postgraduate award to help you grow in the pharmaceutical industry.
This modular course, awarding a Level 9 certificate, aims to introduce learners to the quality systems and the regulatory framework that assures the quality, safety, and efficacy of medicinal products in the pharmaceutical industry.
Why Study Quality and Regulatory Practice at Griffith College?
This certificate will provide students with an enhanced understanding of quality and regulatory practice, with solid grounding in a variety of subjects.
- Enables learners to understand the regulatory framework that underpins biopharmaceutical product development from discovery through pre-clinical research, clinical trials, registration and release in a manufacturing setting.
- Focuses on pharmaceutical quality, quality improvement and risk management practices in Pharmaceutical manufacturing (GMP) and supply, for HPRA, EMA and FDA.
- Enables learners to gain a valuable qualification credential in 12 weeks, for the pharma marketplace.
- Fully QQI-accredited course with an award of 5 credits at Level 9.
- All assessment is assignment-based.
Why work in the Pharma industry in Ireland?
- All of the world's Top 10 pharmaceutical companies have substantial operations in Ireland.
- There are over 30,000 people working in the biopharma industry in Ireland today, with the same number of jobs supported indirectly. (Collins McNicholas', Biopharma Report 2020).
- In 2019, Ireland's largest category of exports was medical and pharmaceutical products, 30% of total exports, an increase of 7% on 2018 to a figure of €49,655 million. (CSO statistical release,
14 February 2020).
- Ireland is the 3rd largest exporter of pharmaceuticals globally. (IDA, Biopharmaceutical Industry in Ireland, 2020).
Course Details
This course comprises one module from the MSc in International Pharmaceutical Business Management.
On successful completion of this module, the learner will be able to:
- Critique the processes involved in bringing drugs from the development stage through to market as registered pharmaceutical medicines.
- Critically analyse the concepts of quality and quality assurance in the development, manufacture, and supply of medicines.
- Evaluate the importance and impact of quality systems in the manufacture and supply of medicines. TBD 133
- Critically assess the role and activities of different regulatory bodies and the necessity for such control in the development, manufacture, and supply of medicines.
- Relate the impact and consequences of poor quality, deviations, complaints and recalls on the organisation, and describe approaches to address and prevent them.
- Critically evaluate the role and responsibilities of key personnel and the organisational structure (QMS, management and Qualified Person (QP)) in ensuring the supply of medicines that meet standards of quality, safety and efficacy.
- Critically assess the latest trends in quality systems, management, process control, medicines and regulation.
Entry requirements
Candidates seeking access to Fundamentals of Quality and Regulatory Practice in the Pharmaceutical Industry module are required to hold either:
1. A Level 8 Honours Degree, 2.2H or higher, in Pharmacy, Science or equivalent discipline.
2. A Level 8 Honours Degree, 2.2H or higher, in business or related discipline, with at least three years Pharmaceutical-related industry experience.
Each candidate's application will be considered individually in accordance with the College's QQI approved quality assurance procedures.
Candidates holding relevant alternative qualifications and those with related experiential learning will be considered under the College's RPL policy.
Candidates who do not satisfy the entry requirements for the programme will be guided in respect of alternative progression options.
Applicants who hold a non-science or business-related degree, and have no relevant business experience on application, may be considered on a case-by-case basis, under the College's QAE procedures for RPL.
All learners are also expected to be proficient in the use of the English language. Where a candidate's mother tongue is not English, he/she will be required to provide proof of proficiency in the English language through satisfactory performance on an internationally recognised test (e.g. TOEFL 575, IELTS 6.5 or other similar English language qualifications).
Application dates
How To Apply
Students who wish to apply for this course may apply directly to Griffith College. They should have obtained a degree at least a level 8 honours degree in pharmacy, science, business or related discipline.
When our Admissions team receive your application they will be in contact with you directly.
Duration
1 Semester Blended Learning
Post Course Info
Students who complete this course may proceed onto another Pharmaceutical Business Management course at Griffith College, including
- MSc in International Pharmaceutical Business Management
- Postgraduate Diploma in International Pharmaceutical Business Management
The skillset needed to work in a modern biopharma plant is evolving with the growing importance of biologics products.
These skills are highlighted in Ireland's National Skills Strategy 2025, where regulatory compliance and pharma co-vigilance roles are in demand by the industry.
Progression from this programme could include (depending on prior experience):
- Clinical - Regulatory Associate
- CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate
- Regulatory Affairs Specialist