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

This Quality Assurance course includes the following topics

Unit 1: Quality Assurance in the Pharmaceutical Industry (Course Outcome 1, Weeks 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)
• Root cause analysis;5WHYS, Fishbone, Pareto & Event tree analysis inference
• Developing CAPA
• Key supplier standards: ISO 9001, API GMP, Excipient GMP
• How to plan, monitor and perform GMP Auditing in line with EU GMP, FDA
• Batch Review and Batch Release, Deviation Handling and Management

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

• Identifying Essential Documents for Record Maintenance
• Good Documentation Practices (GDP) in Pharmaceutical and medical device Manufacturing
• Handling product complaints, Product Recall, and Post-market surveillance
• Principles of documentation, Data integrity and Handling of FDA inspections, FDA warning letters
• Risk Management ICHQ9, ICHQ8, ICHQ7, ICHQ6 & ICHQ10

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

• Quality Management Systems for Manufacturing Processes
• End-to-end lifecycle approach to cleaning validation, cleaning chemistry
• Principles of Calibration and Validation in Pharmaceuticals
• Setting acceptable criteria, process design and qualification
• Quality tracking systems (Phenix, Trackwise, Veeva and VAULT)
• 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

The Quality Assurance course is assessed through one piece of course assessment which requires the learner to work within a group to examine a supplied case study on compliance management and continuous improvement.

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.

You will learning the following on our Quality Assurance course:

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.