Quality Assurance / GMP in Pharmaceutical & Medical Device

Professional Diploma in Foundations of Quality Assurance & GMP in Pharmaceutical and Medical Device Manufacturing
Duration: 10 Weeks | Learning Mode: Blended Online | Contact Hours: 30

Our Professional Diploma in Foundations of Quality Assurance & GMP is designed to provide learners with a practical understanding of Quality Assurance (QA), Good Manufacturing Practice (GMP), compliance, and quality systems within pharmaceutical and medical device manufacturing environments.

The programme explores the principles of quality management, regulatory compliance, documentation practices, traceability, auditing, and continuous improvement. Learners will gain the knowledge required to understand how quality systems operate and contribute to maintaining product quality, patient safety, and regulatory compliance across highly regulated industries.

Learning Mode

Blended Online

Delivered through live online lectures, recorded learning resources, case studies, and tutor support.

• Live online delivery
• Recorded sessions available for review
• One evening per week (6:30 PM – 9:30 PM)
• Delivered over 10 weeks

Fees

€1,095

Payment plans available.

Qualification

Professional Diploma in Foundations of Quality Assurance & GMP in Pharmaceutical and Medical Device Manufacturing
Awarded by City Colleges Dublin.

Course Structure

The programme is delivered across five key areas of study:

Unit 1: Quality Assurance Fundamentals

• Introduction to Quality Assurance principles
• Regulatory requirements and industry standards
• ISO 13485, FDA, and GMP frameworks
• Compliance and continuous improvement

Unit 2: Good Manufacturing Practice (GMP)

• Principles of GMP
• Regulatory guidelines and standards
• Internal and external audits
• Non-conformance management and corrective actions

Unit 3: Documentation, Traceability & Accountability

• Good Documentation Practice (GDP)
• Batch records and processing documentation
• Audit trails and compliance records
• Traceability requirements in regulated manufacturing

Unit 4: Quality Management Systems

• Quality systems and governance
• Sampling plans and quality controls
• Consumer trust and product quality
• GMP application across manufacturing environments

Unit 5: Quality Assurance Systems

• QA system implementation
• Monitoring and testing methodologies
• Benefits and challenges of QA systems
• Quality planning within pharmaceutical and medical device operations

Assessment

Assessment is completed through continuous assessment.

Learners will complete:

• Group-based project work
• Compliance and quality case study analysis
• Evaluation of continuous improvement practices
• Final project submission in Week 10

Who Should Study This Programme?

This programme is suitable for:

• Individuals seeking to enter the pharmaceutical sector
• Individuals seeking to enter the medical device industry
• Quality Assurance professionals
• Manufacturing and production personnel
• Compliance and validation personnel
• Engineers and technicians
• Career changers interested in regulated industries

Learning Outcomes

Upon successful completion, learners will be able to:

• Understand Quality Assurance principles within regulated industries
• Explain the fundamentals of Good Manufacturing Practice (GMP)
• Understand ISO 13485 and related regulatory requirements
• Apply documentation, traceability, and accountability principles
• Understand quality management systems and auditing processes
• Evaluate quality assurance systems within pharmaceutical and medical device manufacturing

Why Choose This Programme?

✔️ Industry-focused Quality Assurance and GMP training
✔️ Learn key pharmaceutical and medical device compliance requirements
✔️ Flexible blended online delivery
✔️ Develop practical knowledge of QA systems and GMP standards
✔️ Explore ISO 13485, FDA, and regulatory frameworks
✔️ Suitable for both newcomers and industry professionals
✔️ Strong foundation for career progression in regulated manufacturing

Location & Start Date

Learning Mode: Blended Online

Duration: 10 Weeks