Certificate in Validation (Certificate in Validation )

Munster Technological University Kerry (TBC)
Key Programme Details
Award

Special Purpose Award

NFQ Level

Level 7 About NFQ

Delivery Method

Online

Mode

Part Time

ECTS Credits

10

Department

Department of Biological & Pharmaceutical Sciences

General Information
Contact

mary.stritch@staff.ittralee.ie

Email

lifelonglearning@ittralee.ie

Phone

0667191701

Address

Lifelong Learning Office
Room R101
Business/IT Building
Munster Technological University - Kerry Campus
Tralee
Co Kerry

Role

Lifelong Learning cocordinator

Important Dates
Application Deadline

19/11/2021

Start Date

17/01/2022

End Date

09/12/2022

About this Course

This programme in validation science provides a 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 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, Quality and Validation. 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.
This one-year programme is delivered over two semesters. The first module, Introduction to Validation, introduces key concepts related to working within a GMP environment and the second module (Validation Science) gives the learner a critical understanding of all aspects involved in process validation. Both modules are delivered through an approach of online delivery of material content, industrial supported seminars, industrial led webinars and industrial championed workshops. The course is examined through a mixture of continuous assessments which includes industrial themed case studies, individual-based assignments and online examinations.

Entry Requirements

Applicants must hold a NFQ Level 6 award in an engineering or science related area. The University's policy in relation to recognition of prior learning (RPL) also applies.

Long Description

The modules to be completed as part of this programme will include:

Introduction to Validation;
Validation Science.

Why Choose This Course

Student Testimonial

"I work full time and am a mother to three children. I have worked in a variety of roles in the highly regulated pharmaceutical industry including roles in engineering, quality assurance, regulatory affairs, projects and validation. Regardless of the role you hold, or if you are thinking about a career in the pharmaceutical or medical device industry, the Certificate in Validation is a sound introductory course. Validation is a vital aspect of Good Manufacturing Practice (GMP) and this course is beneficial to validation engineers and those working in quality and production. Lecturers and staff at IT Tralee have been very responsive and supportive. Lectures and discussions online provide a good opportunity to get the perspective of both the lecturer and other industry professionals on regulations and guidance documents."

SIOBHAN GRIFFIN
ASTELLAS PHARMA 'IRELAND'

Career Opportunities

Graduates of this Certificate in Validation will build on their science or engineering practice competence and will develop skill sets relating to those identified by the EGFSN (Future Skills Needs), the SWRSF in its work on filling the skills needs identified as being a priority and MTU's own experience of the demand for validation skills in its contact with enterprises locally.

Timetable Info

This programme will be delivered online part-time from January 2022 to December 2022.

Provisional Timetable:
Mondays 6pm -8pm (to be confirmed)

Delivery Location

Online

Delivery Notes

Online

Admissions Contact Details
Contact Person

Mary Stritch

Address

Lifelong Learning Office
Room R101
Business/IT Building
Munster Technological University - Kerry Campus
Tralee
Co Kerry

Phone

0667191701

Email

lifelonglearning@ittralee.ie

RPL Information

The University's policy in relation to recognition of prior learning (RPL) applies.

Application Procedures

Apply online at www.springboardcourses.ie

Note: Places will be offered to applicants who submit all application information with uploaded required documentation and meet eligibility criteria, on a first-come-first-response basis.

Closing date for applications to this programme is Friday, 19th November, 2021.

COST:
Fees do not apply to applicants who meet the Springboard+ initiative funding criteria. For employed applicants the HEA will pay 90% of the programme fee, the remaining 10% - €120 will be collected before registration.

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