Professional Diploma in Foundations of Quality Assurance and GMP in Pharmaceutical and Medical Device Manufacturing - Blended Online

This Quality Assurance course includes the following topics:

Unit 1: Quality Assurance in the Pharmaceutical Industry (Course Outcome 1, Week 1 &2)

• Understanding Quality Assurance in the Pharmaceutical and Medical Device Industries
• Regulatory Requirements and Industry Standards (i.e. ISO13485, FDA etc.)
• Non-Compliance and its Consequences
• Ensuring Compliance and Continuous Improvement

Unit 2: Principles and Practices of GMP (Course Outcome 2, Week 3 & 4)

• Fundamentals of Good Manufacturing Practices (GMP)
• GMP Guidelines and Standards set by Regulatory Bodies (ISO13485, FDA, EMA)
• Internal and External Auditing for Compliance
• Identifying Non-Conformances and Implementing Correction Actions

Unit 3: Record Maintenance, Traceability and Accountability (Course Outcome 3, Week 5 & 6)

• Identifying Essential Documents for Record Maintenance
• Good Documentation Practices (GDP) in Pharmaceutical and medical device Manufacturing
• Batch Records and Batch Processing Documentation
• Best Practices for Documentation Review, Audit Trails, and Compliance

Unit 4: Quality Assurance (Course Outcome 4, Week 7 & 8)

• Quality Management Systems for Manufacturing Processes
• Quality Assurance and Consumer Trust
• Sampling Plans and their application
• GMP/ IS13485 in Different Manufacturing Scenarios
• Quality Governance, Challenges and Solutions

Unit 5: QA Systems for Pharmaceutical and Medical Device Manufacturing (Course Outcome 5, Week 9 & 10)

• Introduction to Quality Assurance (QA) Systems
• Benefits and Challenges of Implementing QA Systems
• Tailoring QA Plans for a Pharmaceutical Manufacturing Setting
• Testing Methods and Tools to Monitor QA Systems

Learners, through their individual roles and responsibilities, will examine the case presented and identify improvement practices integrated and evaluate against quality assurance principles and regulation compliance. The project will be due in Week 10 of the programme.

The Quality Assurance course audience is for learners who wish to acquire a foundational understanding of Quality Assurance and Good Manufacturing Practices (GMP) in pharmaceutical manufacturing, including the ability to apply these principles to ensure traceability and accountability.

This aim will empower learners to effectively contribute to the maintenance of high-quality standards in industry, laying a solid foundation for further education and career advancement in pharmaceutical and medical device operations.

1. Recognise the importance of Quality Assurance in the pharmaceutical and medical device industries and the impact of non-compliance on product quality and patient safety.
2. Use appropriate terminology to describe the principles and practices of Good Manufacturing Practices.
3. Gain a basic understanding of ISO13485 which defines GMP.
4. Identify the key documentation required for record maintenance and the essential processes involved in maintaining traceability and accountability in pharmaceutical and medical device manufacturing.
5. Discuss the role of Quality Assurance and the principles and practices of Good Manufacturing Practices in ensuring compliance with regulatory requirements.
6. Illustrate the steps involved in implementing Quality Assurance systems in a pharmaceutical and medical device manufacturing setting.