Process Validation and Regulatory Affairs (Pharmaceutical)

Program Overview

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Process Validation and Regulatory Affairs (Pharma, Postgraduate Diploma, L9, 60 ECTS)

Course Overview

Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing. The aim of the Level 9 taught Postgraduate Diploma of Science in Process Validation and Regulatory Affairs (Pharmaceutical) is to equip learners with competence in the appropriate legal, compliance and industry operational standards.

The programme will enable understanding of all current applicable regulations, quality management systems and effective process validation requirements. Learners will have the knowledge and skills to be able to audit all, or part of, organisation’s formal Quality Management systems. Learners will acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes; ensuring that they will develop skills to address and prepare for the ever-changing environment of regulatory affairs in the Pharmaceutical sector.

This Graduate Diploma of Science is delivered 100% online and designed as an innovative multi-tiered programme to address the needs and requirements of industry-based learners and making education more accessible. It is designed so that learners can opt to select the module streams individually as Special Purpose Awards (six), complete three of the module streams to attain a Level 9 Graduate Diploma or opt for the Level 9 Masters of Science.

Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.

Entry Requirements

• A minimum honours bachelor degree (Level 8) in any discipline with minimum two years relevant work based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning
• A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three years relevant work based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning
• Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered.
• International students must evidence a proficiency in English language for example IELTS 6.5

Course Content

Semester 2

• Auditing and Risk Management: Learners will gain an in-depth understanding of the application of Risk Management within organisational Quality Management Systems. Learners will acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes.
• Advanced Regulatory Affairs (Pharmaceutical): Understanding of the utilisation of standards, FDA and other jurisdictions’ guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the world market.

Semester 1

• Quality Management: The aim of this module is to facilitate an in-depth understanding of quality and quality management, from the various definitions of quality, through to the practical application of systems and processes to manage quality. Learners will be equipped with the knowledge and skills to be able audit all, or part of, organisation’s formal Quality Management systems against defined criteria such as ISO 13485, ISO 9001 or 21 CFR Part 820.
• Regulatory Affairs (Pharmaceutical): Provide learners with an understanding of EU regulatory systems in the pharmaceutical field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the EU market.

Semester 3

• Advanced Process Management: The aim of this modules is to provide the learner with a knowledge of process engineering management in a manufacturing environment. A learner will be able to evaluate process types, designs, layouts, process analysis, forecasting of product, capacity planning while ascertaining a knowledge of current technologies and automation used in the manufacturing.
• Process Validation (Elective): Provide the learner with an overview of process and product validation in manufacturing environments. The focus will be on Process validation with emphases on the tools and techniques that are used in the operations and manufacturing environment; to ensuring that operations are efficient in terms of using as few resources as needed, compliance with regulatory requirements and be effective in terms of meeting customer requirements.
• Computer Systems Validation (Elective): An overview of software validation in a manufacturing or software environment. The focus will be on software validation in a manufacturing or software environment. To evaluate software validation approaches, models, development, implementation, testing and maintenance of validated software.

Career Opportunities

• There are multiple roles a graduate from the programme can seek in disciplines such as Quality Engineering, Management, Auditing, Compliance, Legal and Regulatory affairs.
• Regulatory Engineer, Process Engineer, Validation Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Validation Management, Quality Management, Quality Management Systems, Quality Assurance, Compliance and Auditing Management, Risk Management.

International Opportunities

• The content of the modules will be seen to reflect a globalised environment.
• Learners may apply externally to sit the internationally recognised ISO9001:2015 Lead Auditor Exam, which equips learners to be lead auditors world-wide.

Further Study

• On completing the postgraduate diploma, students can transfer onto the Masters in Process Validation and Regulatory Affairs to complete one 30 credit dissertation module.

Delivery

• Student Induction will take place on the evening of Wednesday 3rd September 2025.
• Classes will commence on week commencing 8th September 2025.
• Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.
• 8 hours per week
• Number of Weeks: 12 per semester
• Number of Days / Evenings per week: 3
• Number of Hours per week: 8
• Delivery Day / Evening: see below

Semester 1

• September – December – Tue & Thu 7pm – 10pm / Fri 1pm – 2pm & 3pm – 4pm

Semester 2

• January – April – Mon & Tue 7pm – 10pm / Fri 1pm – 2pm & 4pm – 5pm

Semester 3

• September – December – Mon & Thu 7pm – 10pm / Fri 3 – 4pm & elective (either 4pm – 5pm or 5pm – 6pm)

Time Commitment

• Each 5 credits will normally equate to approximately 100 Total Learning Hours. Total Learning Hours includes the time you spend in class (lectures, tutorials, practical elements) and the time you spend completing work outside of college.

Assessment

• Continuous assessment (100% online). No end of semester exams.

Qualification

• Postgraduate Diploma in Science in Process Validation and Regulatory Affairs (Level 9, 60 ECTS)

Fees

• €8,500** Springboard+ funded in 2025.
• Successful employed applicants who meet the eligibility requirements will qualify for 90% funding and pay balance of 10% ie. €850.

Application Deadline

• Limited Places
• Places are allocated on a first come first served basis, prioritizing unemployed and returning applicants.
• The programme will be closed once the maximum number of applicants is reached.
• Final cut off for applications, if spaces are still available, will be Friday 18th July 2025.
• Programmes run subject to viable numbers.

Program Outline

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Degree Overview:

The Level 9 Taught Graduate Diploma of Science in Process Validation and Regulatory Affairs (Pharmaceutical) aims to equip learners with competence in the appropriate legal, compliance, and industry operational standards. Learners will gain the knowledge and skills to audit Quality Management systems, evaluate evidence against defined criteria, and determine the effectiveness of systems and processes. The program emphasizes critical thinking, problem-solving, decision-making, professionalism, and management techniques. It is delivered 100% online and designed as an innovative multi-tiered program to address the needs of industry-based learners. Learners can select individual module streams as Special Purpose Awards, complete three module streams for a Graduate Diploma, or opt for a Masters of Science.

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Outline:

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Semester 1:

• Quality Management: This module provides an in-depth understanding of quality and quality management, covering definitions, practical applications of systems and processes, and auditing against criteria like ISO 13485, ISO 9001, or 21 CFR Part 820.
Learners develop skills to become leaders and innovators in quality management.
• Regulatory Affairs (Pharmaceutical): This module covers EU regulatory systems in the pharmaceutical field, including the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and submission pathways.
It explores theory, regulations, tools, and techniques used in the industry, equipping learners with competence in legal, compliance, and operational standards.

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Semester 2:

• Auditing and Risk Management: This module focuses on the application of Risk Management within organizational Quality Management Systems.
• Advanced Regulatory Affairs (Pharmaceutical): This module covers the utilization of standards, FDA and other jurisdictions' guidance documents, and technical writing.
It explores the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and submission pathways in the global pharmaceutical market.

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Semester 3:

• Advanced Process Management: This module provides knowledge of process engineering management in a manufacturing environment.
Learners evaluate process types, designs, layouts, process analysis, forecasting, capacity planning, and current technologies and automation used in manufacturing.
• Computer Systems Validation (Elective): This module covers software validation in a manufacturing or software environment, evaluating software validation approaches, models, development, implementation, testing, and maintenance.
It emphasizes validation management, reporting, and risk management in a manufacturing/software environment.

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Course Schedule:

• The program runs online from September 2024 to December 2025.
• 8 hours per week.
• 12 weeks per semester.
• 3 days/evenings per week.
• Semester 1: September ’24 – December ’24 – Tue & Thu 7pm – 10pm / Fri 1pm – 2pm & 3pm – 4pm
• Semester 2: January ’25 – April ’25 – Mon & Tue 7pm – 10pm / Fri 1pm – 2pm & 4pm – 5pm
• Semester 3: September ’25 – December ’25 – Mon & Thu 7pm – 10pm / Fri 3 – 4pm & elective (either 4pm – 5pm or 5pm – 6pm)

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Assessment:

• Continuous assessment (100% online).
• No end of semester exams.

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Teaching:

• Lectures are delivered 100% online via Moodle/MSTeams.
• Lectures are recorded and available to watch back.

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Careers:

• Graduates can seek roles in Quality Engineering, Management, Auditing, Compliance, Legal, and Regulatory affairs.
• Potential roles include Regulatory Engineer, Process Engineer, Validation Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Validation Management, Quality Management, Quality Management Systems, Quality Assurance, Compliance and Auditing Management, and Risk Management.
• The program's content reflects a globalized environment, with the regulatory affairs module stream focusing on EU, US, and worldwide regulatory affair bodies.

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Other:

• On completing the Postgraduate Diploma, students can transfer onto the Masters in Process Validation and Regulatory Affairs to complete one 30 credit dissertation module.
• Each 5 credits equate to approximately 100 Total Learning Hours, including class time and work outside of college.
• The workload will increase at particular times, such as when assignments are due.