Certificate in Continuing Professional Development in Validation Science (Certificate in Continuing Professional Development in Validation Science)

University College Cork (CVS)
Key Programme Details
Award

Certificate (Special Purpose Award)

NFQ Level

Level 7 About NFQ

Delivery Method

Online

Mode

Part Time

ECTS Credits

10

Department

ACE

General Information
Contact

Lorna Moloney

Email

Ace.Springboard@ucc.ie

Phone

0876931100

Address

Adult Continuing Education (ACE),
University College Cork,
The Laurels,
Western Road,
Cork.

Important Dates
Application Deadline

19/08/2022

Start Date

01/09/2022

End Date

31/05/2023

About this Course

This special purpose award (SPA) is a joint collaboration between UCC, MTU (Cork and Tralee), South West Regional Skills Forum and industrial partners (Biopharma, Pharma and MedTech manufacturers) in response to a critical skills need identified in validation science in the South West Region. The aim of which is to guarantee a pipeline supply of qualified individuals with consistent delivery across South Western universities and consistent learnings aligned with industrial needs on validation. This programme has been specifically developed based on evidence of skills needs and demand from employers for a new programme to close a key skills gap across this sector. The SW Regional Skills Forum established an Industry SME Group of 12 companies to scope out the specifics of needs and to co-develop a new programme with MTU and UCC that directly responds to the requirement of employers.

This successful partnership involves a standard delivery of online material content, shared industrial-led workshops and shared student intake. This harmonised approach gives the assurance of a larger network of attractive graduates, as requested from industry. The list below comprises the companies that actively contribute to the programme delivery:

Janssen Sciences Ireland (Biologics)
AbbVie
Astellas
Boston Scientific
MSD Brinny
Alcon
DPS Engineering
Hovione
PM Group
LSC Consultants
GSK Thermofischer

This SPA is an accredited level 7 qualification in Validation Science (10 credits) delivered part time by evening over one academic year (26 weeks) which is suitable for all applicant categories seeking to up-skill/cross-skill in order to secure employment for purposes of joining, re-entering or for career progression in the Biopharma, Pharma and MedTech sectors. The course is designed for maximum flexibility for students to complete the course part time and completely online.

This industrially focused course provides students an understanding of the importance of validating manufacturing processes (aseptic, plant, utilities) as well as the emerging trends/technologies in these expanding industries (e.g. vaccine development and automation). It is committed to producing graduates with the knowledge and transversal skills to work successfully in the highly regulated manufacturing environments and more importantly, be able to adapt to the future demands of this sector. Roles such as production/manufacturing, quality assurance, regulatory affairs, commissioning, qualification and validation roles are targeted within the Biopharma / Pharma /Medtech industries.

Promotional and recruitment support by the South West Regional skills forum is invaluable in helping to achieve the target recruitment of students. The industrial partners provides approx. 70 % of student intake and are committed to supporting the programme to close the gap on the skills need in this area. This Validation Science program was a key competence driver to support the Pharma/Biotechnological developments in the South West region; Pfizer €300 million investment in 2020; Janssen developed a new manufacturing facility (€300m) in 2019; MSD made a recent €280m investment into its Irish sites. The healthcare sector remains a very important and vibrant contributor to the economy in the area: over 10,000 people are directly employed by the Pharma and MedTech sector.

Entry Requirements

Candidates must hold a minimum level 6 qualification (120 credits) or equivalent in an engineering or science discipline.

Long Description

This special purpose award (SPA) is a joint collaboration between UCC, MTU (Cork and Tralee), South West Regional Skills Forum and industrial partners (Biopharma, Pharma and MedTech manufacturers) in response to a critical skills need identified in validation science in the South West Region. The aim of which is to guarantee a pipeline supply of qualified individuals with consistent delivery across South Western universities and consistent learnings aligned with industrial needs on validation. This programme has been specifically developed based on evidence of skills needs and demand from employers for a new programme to close a key skills gap across this sector. The SW Regional Skills Forum established an Industry SME Group of 12 companies to scope out the specifics of needs and to co-develop a new programme with MTU and UCC that directly responds to the requirement of employers.

This successful partnership involves a standard delivery of online material content, shared industrial-led workshops and shared student intake. This harmonised approach gives the assurance of a larger network of attractive graduates, as requested from industry. The list below comprises the companies that actively contribute to the programme delivery:

Janssen Sciences Ireland (Biologics)
AbbVie
Astellas
Boston Scientific
MSD Brinny
Alcon
DPS Engineering
Hovione
PM Group
LSC Consultants
GSK Thermofischer

This SPA is an accredited level 7 qualification in Validation Science (10 credits) delivered part time by evening over one academic year (26 weeks) which is suitable for all applicant categories seeking to up-skill/cross-skill in order to secure employment for purposes of joining, re-entering or for career progression in the Biopharma, Pharma and MedTech sectors. The course is designed for maximum flexibility for students to complete the course part time and completely online.

This industrially focused course provides students an understanding of the importance of validating manufacturing processes (aseptic, plant, utilities) as well as the emerging trends/technologies in these expanding industries (e.g. vaccine development and automation). It is committed to producing graduates with the knowledge and transversal skills to work successfully in the highly regulated manufacturing environments and more importantly, be able to adapt to the future demands of this sector. Roles such as production/manufacturing, quality assurance, regulatory affairs, commissioning, qualification and validation roles are targeted within the Biopharma / Pharma /Medtech industries.

Promotional and recruitment support by the South West Regional skills forum is invaluable in helping to achieve the target recruitment of students. The industrial partners provides approx. 70 % of student intake and are committed to supporting the programme to close the gap on the skills need in this area. This Validation Science program was a key competence driver to support the Pharma/Biotechnological developments in the South West region; Pfizer €300 million investment in 2020; Janssen developed a new manufacturing facility (€300m) in 2019; MSD made a recent €280m investment into its Irish sites. The healthcare sector remains a very important and vibrant contributor to the economy in the area: over 10,000 people are directly employed by the Pharma and MedTech sector.

Timetable Info

3, Combination

Delivery Notes

Lectures will be delivered entirely online via UCC’s Canvas virtual learning environment. Lectures will be delivered using a blended online approach with pre-recorded material released on a weekly basis prior to a live interactive discussion class with the subject lecturer. Lectures can be viewed at any time, from anywhere, and as often as desired. Detailed lecture notes will accompany each lecture as well as recommended reading. Weekly learning activities will be provided to the learner which will focus and foster active learning directly relevant to the weekly topic and the discussion forums enable peer-to-peer engagement which ensures collaborative and enhanced learning for all. Field work will resume when guidelines allow.

Course commitment: An ability to manage and allocate time to course content each week is necessary. Students are expected to participate in the weekly live class and to engage with the discussion forum to interact with course lecturers, tutors, and other students, where they can discuss content and engage in module material.

Applicants need to be aware of the IT student checklist below before applying:
* You will need access to a laptop or desktop computer running a modern supported operating system with all software updates.
* Some of UCC’s services (e.g. the Canvas Virtual Learning Environment) link to an external site and also have mobile apps for iOS and Android Devices that you may wish to use as part of your studies. However, we recommend using your desktop web browser for submission of assessments.
* You should always use the most current version of your preferred browser. In general, we recommend the Chrome Web browser (Important Note: Internet Explorer will not work with Canvas).
* We recommend a reliable broadband connection with at least 2Mbps or more.
* You will require an Office suite of software (Microsoft Office or equivalent) and a PDF reader. You should always use the latest version of this software. All UCC students will have access to Office 365 which includes software such as Word/Excel/Powerpoint etc. once registered.

Admissions Contact Details
Contact Person

Lorna Moloney

Address

ACE (Adult Continuing Education)
The Laurels,
University College Cork
Cork

Phone

087-6931100

Email

Ace.springboard@ucc.ie

Application Procedures

CV - Please upload an up-to-date CV.
Academic transcripts (results) or parchment (if results are included) - Please upload evidence of your previous educational qualifications in 1 file. If you do not have your UCC transcript(s) on hand, there is no need to order one, we can view your results on our internal system.

Personal / Motivational Statement - Please upload a document. In 500 words or less, please state: 1) Why you wish to study this programme at University College Cork and 2) How you meet the programme entry requirements.

Transcripts showing educational evidence for course.

Recognition of Prior Learning (RPL)? - If applying via Recognition of Prior Learning (RPL) – (meaning you do not meet the minimum entry requirements of an NFQ Level Degree but wish to apply based on experience) please provide a work, personal or academic reference to support your application.