Certificate in Biopharma and Med-Technology (Tullamore)
Why take this course?
The aim of this programme is to up-skill people (irrespective of their current employment status) to work in the growing bio-pharma/med-tech sector. It is envisaged this target group will be a mix of people who currently work in the sector seeking to up-skill and people seeking to gain entry to employment in this sector.
• Active Pharmaceutical Ingredient (API) Manufacturing
• Pharmaceutical Manufacturing
• Biopharmaceutical Manufacturing
• Medical Devices and Sterile Manufacturing
• In-Process Testing
• Process Validation
• Qualifications: Performance, Installation, Operational (PQ OQ IQ)
• Good Manufacturing Practices and Good Automated Manufacturing Practices (GAMP)
Systems and Supports
• Cleaning Validation
• Quality Control and Finished Product testing and release
• Analytical Validation
• Regulatory Requirements
• Quality Risk Management
• Deviations and Corrective Action Preventative Action (CAPA)
• Quality Management Systems and Lean Six Sigma
What will I experience?
On completion of this programme the learner should be able to:
1. Describe what the Bio Pharma and MedTech Industries represent.
2. Identify the typical roles and departmental functions that exist within the BioPharma and MedTech sectors.
3. Explain the role of Guidelines, Regulations, Standards and Laws as applicable to the BioPharma and MedTech sectors
4. Outline the Pre-market activities and market place risks leading in the BioPharma and MedTech sectors
5. Explain and understand the role of Environmental, Health and Safety Management.
6. Identify and explain the role of Quality Assurance
7. Understand the steps involved in the development, manufacture, and delivery of finished Biopharma and Medtech products
8. Describe the principles of quality management and explain the importance of documentation, including change control processes, and write a standard operating procedure.
9. Explain the steps of pharmaceutical and medical device registration including sourcing and interpreting directives, guidelines and documents regulating pharmaceutical and medical device manufacture.
10. Outline the necessity for, function and impact of GMP within industry and discuss how GMP regulations have developed including the current issues affecting the Biopharma and Med-Technology sector.
11. Identify the role and functions of the Quality Control in manufacturing. Review the QC testing pathway and describe common test methods employed by QC.
12. Explain the elements of effective sampling
13. Describe the processes used to manage non-conformances and improvement opportunities in a GMP environment.
14. Explain the approaches to, concepts, and theories of Lean Manufacturing, including key aspects of Just in Time and Six Sigma.
- Course Duration:
- 6 Months
- Course NFQ Level:
- Level 6
- Dept of Lifelong Learning
- Minimum Entry Requirements:
Mature applicants (i.e. over 23 years of age)
Grade O6 at ordinary level in five subjects in the Leaving Certificate examinations. Two of these subjects must be mathematics and a language (English or Irish)
Any QQI level 5 qualification
an approved equivalent qualification.
Careers & Opportunities
This introductory course is suitable for people wishing to understand and gain entry to the Biopharma and Med- Technology sectors and also for people within the sector wishing to move to quality assurance/ validation and/or regulatory roles.