Certificate in Biopharma and Med-Technology - Castlerea (Springboard)
Why take this course?
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
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
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
10. Outline the necessity for, function and impact of GMP within
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:
- 16 Weeks
- Course Commencement Date:
Please note: Institute induction is on Saturday 21 September 2019 from 9.30am to 1.00pm. Attendance on that date is compulsory.
- Course Award:
- Course NFQ Level:
- Level 6
- Dept of Lifelong Learning
- Minimum Entry Requirements:
Mature applicant or 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). Or Any QQI level 5 qualification is acceptable.
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.