Certificate in Validation Science

Cork Institute of Technology (CR_SVASC_7 )
Key Programme Details
Award

Certificate in Validation Science

NFQ Level

7 About NFQ

Delivery Method

Online, Classroom - Evening

Mode

Part Time

ECTS Credits

10

Department

Process Energy and Transport Engineering

Skills Area

Engineering, manufacturing and construction

General Information
Contact

Ciara Lavelle

Email

BioPharmaSpringboard@cit.ie

Phone

021 4326264

Address

CAMMS
Cork Institute of Technology,
Bishopstown,
Cork.


Role

CAMMS Project coordinator

Important Dates
Application Deadline

29/08/2018

Start Date

19/09/2018

End Date

31/08/2019

About this Course

This Special Purpose Award in Validation Science provides an accredited level 7 qualification in Validation Science over one year for individuals who are seeking to up-skill or cross-skill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries.

This Special Purpose Award in Validation Science has been developed in response to the requests from the industrial participants in the South Western Skills Forum.

This programme targets employment roles in production/manufacturing, quality assurance, regulatory affairs,commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device manufacturing companies.

Objectives

This Special Purpose Award in Validation Science was developed in response to the requests from the industrial participants in the South Western Skills Forum. This forum has identified Validation Science as a key competence required in response to the Biotechnological developments in the South West region (MSD Brinny, Eli Lilly, Biomarin, Regeneron, Janssen Biologics and GE Biopark, LSC, PM Group, Boston Scientific, Alcon, Sanmina, Hovione and DPS).

Entry Requirements

All qualified candidates are required to have a minimum of a Level 6 qualification (120 credits), or equivalent* in an engineering or science discipline. Candidates may also be interviewed for positions on the programme.

*For the purposes of entry to the Certificate in Validation Science, the following have been deemed as equivalent to a Higher Certificate in Science or Engineering:

- Certificate in the Science of Biotechnological Manufacturing Operations with appropriate work experience in the pharma, biopharma or medtech sectors.
- A trade qualification with appropriate work experience in the pharma, biopharma or medtech sectors.
- First two years successfully passed in a BSc or BEng programme.
- BA in the more mathematical areas e.g. Economics/Geography/Maths.


Long Description

This Special Purpose Award in Validation Science provides an accredited level 7 qualification in Validation Science over one year for individuals who are seeking to up-skill or cross-skill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries.

This Special Purpose Award in Validation Science has been developed in response to the requests from the industrial participants in the South Western Skills Forum.

This programme targets employment roles in production/manufacturing, quality assurance, regulatory affairs,
commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device
manufacturing companies. This is an industrially focused course where students gain valuable knowledge and key skills in subject areas pertinent to working in highly regulated manufacturing environments such as GMP, QA, QC and Validation.
Students will attain a knowledge and understanding of the principles of quality regulation as required by the principles of current Good Manufacturing Practice. The importance of validation of equipment, plant, utilities, processes and procedures in industry will be shown to be an essential approach to consistently producing products of the intended quality. The learner will gain an understanding of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry. The proposed modules are focused not only on the biotechnological industries but also find applications into other regulatory compliant environments such as the pharmaceutical and medical technology sectors.
This one-year programme is delivered over two semesters of 13 weeks by online delivery and in the classroom followed by examinations. The course uses a mixture of continuous assessments (case studies project, practical and industrial visits) and formal exam assessments. Integral elements of this one-year springboard programme are the career professional development (CPD). Cork Institute of Technology (CIT) also offers extensive careers services and guidance as well as support services for students who are taking the tentative steps back into education. A structured Continuous Professional Development (CPD) is in place to develop the students skills in the recruitment and selection process for employment in the sectors identified above.
The first introductory module is a blended module and will consist of a mixture of online teaching, lectures and workshops. Several industry champions will deliver workshops and webinars that will reinforce the fundamental content delivered by the academic lecture team. Industry generated case studies focusing on different aspects linked to different learning outcomes, online lectures/seminars, Industry Guest Lecturers for webinars. The second module gives the learner a broad understanding of the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical and medical device industries. The principles of risk assessment techniques in validation are applied.

Why Choose This Course

This Special Purpose Award in Validation Science provides an accredited level 7 qualification in Validation Science over one year for individuals who are seeking to up-skill or cross-skill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries.
This Award targets employment roles in production/manufacturing, quality assurance, regulatory affairs, commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device manufacturing companies. This is an industrially focused course where students gain valuable knowledge and key skills in subject areas pertinent to working in highly regulated manufacturing environments such as GMP, QA, QC and Validation.
Students will attain a knowledge and understanding of the principles of quality regulation as required by the principles of current Good Manufacturing Practice. The importance of validation of equipment, plant, utilities, processes and procedures in industry will be shown to be an essential approach to consistently producing products of the intended quality. The learner will gain an understanding of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry. The proposed modules are focused not only on the biotechnological industries but also find applications into other regulatory compliant environments such as the pharmaceutical and medical technology sectors.

Career Opportunities

The Irish Business and Employers Federation (IBEC) and BioPharmaChem Ireland (BPCI) announced in February 2018 that MSD will create 350 jobs in Ireland which bolsters the country’s status as a thriving hub for the biopharmaceutical sector. BPCI have also highlighted opportunities for the pharma/life science sector in Ireland as a result of the pending BREXIT. The Irish Medtech Association has stated that as many of 9 out of the world’s top 10 medical technological companies have a base in Ireland, employing 40,000 employees. The anticipated expansion rate and replacement demand in BioPharmaChem outlined in the Expert Report Group on Future Skills Needs (2016) highlighted projections of 8,400 trained personnel required over the next five years. Note in 2015, 41,500 people were employed in manufacturing in the South West and over 25% (10,000) were associated with “high-tech” in the pharmaceutical sector.
(Regional Labour Market Bulletin, 2016).

Timetable Info

Semester 1: Industry Workshops 4 times over the semester, 6-9 pm Wednesdays. You will be given more information on the specific Wednesdays once the programme commences in September. Online presentations and webinars to be taken at your own time throughout the semester.

Semester 2: Lectures every Wednesday 6 - 9 pm.

Note:
Lectures and workshops in Semester 1 run between 12th September to 18th January 2018

Lectures in Semester 2 run between 28th January 2019 to 24th May 2019.

Delivery Location

Online and CIT Bishopstown

Delivery Notes

Blended

Admissions Contact Details
Instructor

Ciara Lavelle

Address

CAMMS
Cork Institute of Technology,
Bishopstown,
Cork

Phone

021 4326264

Email

ciara.lavelle@cit.ie

Application Procedures

Please ensure you provide the following documents with your application:
• Qualification certificates showing academic eligibility
• Up to date Curriculum Vitae
• Documentation showing Springboard+ eligibility.
These may be scanned and uploaded as a single document or alternatively uploaded as a zip file. Your application cannot be approved without these documents.

The course fees are €1,250. Unemployed candidates that qualify for springboard funding are exempt from this fee. Those in employment qualify for 90 % funding and are required to pay €125.