Certificate in Bio-pharma and Med-Technology (Longford - September 2019)

Athlone Institute of Technology (LL Course will take place in Longford Town)
Key Programme Details
Award

Certificate in Biopharma and Med-Technology

NFQ Level

6 About NFQ

Delivery Method

Mixed, Classroom - Evening

Mode

Part Time

ECTS Credits

20

Department

Department of Lifelong Learning

General Information
Contact

Janinr King

Email

jking@ait.ie

Phone

090 6483050

Address

Department of Lifelong Learning, Athlone Institute of Technology, Dublin Road, Athlone, Co Westmeath.

Role

Course Co-ordinator

Important Dates
Application Deadline

19/09/2019

Start Date

21/09/2019

End Date

07/02/2020

About 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.

Objectives

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.

Entry Requirements

Mature applicants (i.e. over 23 years of age)
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
or
an approved equivalent qualification.

Long Description

This programme is designed to apply across the industries e.g. Industrial Pharma, BioPharma and MedTech. Prospects typically arise in these industries regionally (recognising Longford, Westmeath, Offaly and Laois as industry centres), nationally and abroad. Furthermore, as a result of Brexit, it is envisaged that there will be an increase in those requiring the skills and competencies acquired through the completion of this programme.

It is intended that this course is suitable for three cohorts of individuals:
1) Those who wish to understand and gain entry to the Biopharma and Med-Technology sectors
2) Individuals with a production, science, logistics, technical or quality background who want to make a career change into the growing pharmaceutical, bio pharmaceutical and medical device sectors
3) Those already working in these sectors wishing to reskill, for example those within the sector wishing to move to quality assurance/ validation and regulatory roles.

Course Content:
Manufacturing Environment
• 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




Timetable Info

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.

Delivery Location

Primary location is Longford Town.

Induction on 21 September 2019 will take place in the Main Campus, Athlone Institute of Technology, Dublin Road, Athlone, Co Westmeath.

Delivery Notes

This programme is primarily classroom based, however all course notes will be uploaded to Moodle, our virtual learning environment, so students can access these anytime, anywhere using their phone, tablet, pc or laptop.

Admissions Contact Details
Contact Person

Janine King, Department of Lifelong Learning

Address

Department of Lifelong Learning, Athlone Institute of Technology, Dublin Road, Athlone, Co Westmeath.

Phone

090 6483050

Email

jking@ait.ie

Application Procedures

Applications to be made only on www.springboardcourses.ie

This is a FREE programme for those that are eligible - see details of eligibility below.

When making your application (or as soon as possible after) you MUST EMAIL to lifelonglearning@ait.ie a brief recent CV and a scan / photo of one of the following documents to demonstrate your eligibility to be offered a place on the programme:
1) If you are employed: a recent payslip / most recent P60 / letter from my employer confirming this (amounts may be redacted from financial documents).
2) If you are unemployed: a DSP payment slip / letter from DSP confirming your payment type/what you are signing for.
3) If you are a returner who has been on home or other caring duties for 9 of the last 12 months OR you are economically dependent on a partner or spouse and I have been unemployed for 9 of the last 12 months you must supply a notarised affidavit confirming this (a template for this is available here: https://springboardcourses.ie/pdfs/Declaration%20for%20Returners%20(V2%202018).pdf
4) If you were previously self employed: a letter/statement from Revenue stating that I am no longer trading or a similar letter from my
(former) accountant.

Applications that do not EMAIL the relevant documentation cannot be assessed for a place on the programme, and places are limited, so it is imperative that you EMAIL all necessary documentation when making your application or as soon as possible after.

With regard to eligibility for a place on this programme, if offered a place you will also be asked to declare that you have lived in an EU country for three years out of the last five in addition to the requirements above.

Please contact Maria Slevin, Lifelong Learning, AIT if you have any queries in relation to this - email mslevin@ait.ie tel 0906483052

The personal data being collected is required for assessing your eligibility for a place on this programme. If you are successful and accept an offer of a place then the details required for registration will be retained in line with our Student Privacy Policy – www.ait.ie/gdpr. Your redacted payslip/ P60 record will be held securely by the Lifelong Learning Department for at least 6 years, in line with ESF funding requirements. If you are not successful, or if you withdraw from the programme within six weeks of commencement, your data will be destroyed securely.