Certificate in Biopharma and Med-Technology (Tullamore) (Springboard)
Why take this course?
This programme is aimed at those already working in or who are interested in pursuing a career in Industrial Pharma, BioPharma and MedTech. The aim of this programme is to provide the learner with the opportunity to develop the technical, scientific, interpersonal knowledge, skills and competencies required for roles in organizations. The course will assist the learner in becoming a more effective and competent employee. It is also suitable for unemployed persons that meet the entry requirements. Developed in association with industry leaders, this specialist course promotes a critical awareness of the most recent advances in the field of laboratory science, biopharma and medtech technologies and practices. This programme is a direct response to support our industry partners in the midlands and beyond as they try to mitigate against the perceived risk owing to Brexit including the expected changes in all aspects of business and management.
What will I experience?
The main objective of the Certificate in BioPharma and Medtech is to provide learners of all backgrounds with the opportunity to explore and develop their interest in these industries and sectors.
This course will give learners the opportunity to further their skill, or re-skill and make a positive contribution to the economy through gaining an understanding of the dynamics of business and in particular from a Biopharma and Medtech industry perspective ensuring they are better at making decisions, solving problems and skilled for the workplace of the future.
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
16 weeks; part-time
One evening per week 6.00pm to 10.00pm
PLUS three Saturdays per semester.
Please note there will be Induction on Saturday 21 September 2019 - this is compulsory for all applicants.
- 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 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.