Overview
Course outline
Entry
Career path
How to apply

Course Overview

Empower your future in the pharmaceutical industry with our Postgraduate Diploma in Pharmaceutical Quality Systems Validation and Technology. Master the skills to drive innovation, ensure regulatory compliance, and lead technological advancements in quality assurance and validation. Unlock a career that transforms lives and shapes the future of healthcare.

This Post Graduate Diploma Programme is a unique blend of technology, quality and validation. The programme is designed to equip learners with advanced knowledge and skills in pharmaceutical quality systems, validation processes, and technology.

MSc option also available.

Modules Include:

Processes, Production and Pharmaceutical Quality Systems
Regulatory Landscape of Pharmaceutical Business
Process Validation for Pharmaceutical Manufacturing & Cleaning
Research Methods
Operational Excellence & the Science of Innovation
Analytical Method Validation
Computer System Validation and Assurance
Pharmaceutical Packaging and Labelling

Developed and taught by experienced academics and industry lecturers, this course is delivered through blended learning, 2 evenings per week online and 2 Saturdays per month in person. 

Accreditation: QQI Postgraduate Diploma in Pharmaceutical Quality Systems Validation & Technology

Collaborating College: Griffith College Dublin

Next Intake: September 2025. Now accepting applications.

Course Outline

This course is delivered 2 evenings per week online and 2 Saturdays per month in person.

A full-time option is available for International Students

Module 1: Process, Production and Pharmaceutical Quality Systems

Pharmaceutical Manufacturing & Plant Design
Emerging technologies of Industry 4.0/5.0 & Pharma 5.0
Quality by Design (QbD) and Process Analytical Technologies (PAT)
Validation Lifecycle
Pharmaceutical Quality Systems

Module 2: Regulatory Landscape of Pharmaceutical Business

Pharmaceutical Regulatory Environment
Pharmaceutical Regulatory Standards and Guidelines
Pharmaceutical Regulations in Manufacturing Plant
Clinical Trials Regulation
Pharmaceutical Regulations in Drug Distribution
Waste Management and Pollution

Module 3: Process Validation for Pharmaceutical Manufacturing and Cleaning

Regulatory Requirements for Process Validation
Risk-Based Approach to Process Validation
Process Validation Protocols and Documentation
Execution of Process Validation Studies
Statistical Tools and Techniques in Process Validation
Process Change Control and Management
Cleaning Validation Programs
Communication of Validation Results

Module 4: Research Methods

The research process and critical thinking
Conducting literature review
Research questions and hypotheses
Ethical and data integrity considerations
AI in research
Quantitative methods
Qualitative methods
Transforming research ideas to product and services
Project management

Module 5: Operational Excellence & the Science of Innovation

Operational Excellence Implementation Models
The Lean Enterprise
Six Sigma
CAPA
Design for Six Sigma

Module 6: Analytical Method Validation

Introduction to Analytical Method Validation
Regulatory Background and Requirements
Statistical Tools for Method Validation
Practical Aspects of Method Validation
Preparing for Method Validation
Validation of Analytical Methods
Verification of Compendial Methods
Transfer of Analytical Methods and Procedures
Maintaining Method Validation (Lifecycle Management)

Module 7: Computer System Validation and Assurance

Introduction to Computer Systems Validation and Assurance (CSV&A)
Risk-Based Approach to CSV&A
Validation and Assurance Documentation
Validation and Assurance Execution and Compliance
Data Integrity and Security in Computerised Systems
Ongoing Maintenance and Periodic Review
Integration of CSV&A with Quality Management Systems

Module 8: Pharmaceutical Packaging and Labelling

Introduction to Pharmaceutical Packaging and Labelling
Pharmaceutical Packaging Design
Regulatory Requirements for Pharmaceutical Labelling
Packaging Materials and Technologies
Labelling Requirements and Artwork Design
Packaging and Labelling Process Validation
Risk Assessment in Packaging and Labelling
Quality Assurance and Control in Packaging and Labelling
Sustainability and Environmental Considerations

Entry Requirements

This course is suitable for those with a minimum qualification of higher degree at NFQ Level 8 with a 2.2 award or higher in Science, Quality, Manufacturing, Engineering, Data Analytics, Project Management, Medicine or related discipline.

Recognition of prior learning will also be taken into account

Career Options

This highly desired postgraduate diploma will help you open the door to an exciting and successful career in the Pharma and Biotech industries.

Potential Roles in the Pharma industry include:

Operations roles – managers / supervisors / process engineer
Process validation / product validation / computer systems validation
Digital transformation / automation / PAT deployment
Business intelligence / data analysis
Engineering / new product introduction / product programme manager
Regulatory affairs / compliance specialist
Medical vigilance / surveillance and risk management
Process improvement specialists / managers
Quality assurance specialist / manager

Our Professional Development team, through individual coaching and mentorship, develop each student to their greatest potential – developing their networking and communication and presentation skills, which ensures that graduates develop a suitable career path. This Career Development strategy has proven to be very successful, with over 70% of Innopharma graduates gaining employment or advancing further their careers in the industry within six months of qualification.

As a result of our proven track record, many organisations and recruitment agencies now contact us directly, requesting students to fill open roles they have.

Apply Now

Our admissions team are on hand to assist you with your application and answer any questions you may have on the course.

Students who wish to apply to this course should follow the following application process.

Step 1 (part-time students): Enquire through the form at the top right of this page

Step 1 (full-time International students): Apply through the form on our International Students page

Step 2: A member of our team will be in contact through phone or email

Step 3: If you are deemed to be eligible for the course, you will be sent an application form by email. You MUST fill in this application form and attach all necessary *documents (CV, ID, Transcripts, etc.)

Step 4: On submission of the completed application form and all documentation, your application will be sent to the associated department for final approval. You will receive an e-mail confirming your place on the programme. (Note: This process can take up to one week particularly during busy admission periods.)

*We accept scanned documents in a pdf format. Pictures of documents are not accepted.

Please note at any time if you have any questions please do not hesitate to contact us by email on admissions@innopharmalabs.com or call us (01) 485 334