Higher Diploma in Quality Systems Validation with Data Analytics for the BioPharmaChem industry (Cork) (Higher Diploma in Quality Systems Validation with Data Analytics for the BioPharmaChem industry (Cork))

Munster Technological University (9446)
Key Programme Details
Award

Higher Diploma

NFQ Level

Level 8 About NFQ

Delivery Method

Blended

Mode

Full Time

ECTS Credits

60

Department

Physical Sciences

General Information
Contact

Gráinne Conneely

Email

grainne.conneely@mtu.ie

Phone

021 433 5595

Address

Bishopstown, Cork

Role

Course Coordinator

Important Dates
Application Deadline

31/07/2022

Start Date

19/09/2022

End Date

31/05/2023

About this Course

The Higher Diploma in Quality Systems Validation with Data Analytics is a 60 credit, 12-month full-time programme. The course is industry focused, to address scientific skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & MedTech sectors. The HDip is designed with Industry to upskill graduates to become specialised in Validation and Quality Systems, with a strong data integrity focus.

Validation, Statistical Quality Control and Data Analytics are areas that have been identified where skilled graduates are needed. The regulatory and validation sections of the course provide an overview of the regulatory requirements for industry. This includes the requirements of regulatory bodies on validation of software systems used in industry and regulatory requirements on electronic records and signatures, Data Integrity and Quality Risk Management as applied to Computer Systems Validation. The programme places a strong emphasis on professional development, management and leadership skills, all of which will allow students to develop their career aspirations.

There has been substantial investment in the BioPharmaChem sector, enhancing the development of new skills from traditional small-molecule manufacturing. Increasing automation and advances in manufacturing processes from batch to continuous manufacturing is critical to creating the optimum manufacturing environment, utilizing skid technology and prioritizing innovation.

This programme is aimed at those wishing to transition in the latest developments in data analytics and validation, providing a strong talent pipeline for industry, combining knowledge, skills and expertise. There will be a strong data integrity focus, producing graduates with expert knowledge on the methodologies to ensure quality validation and associated data analytics. The HDip places significant emphasis on student learning. It adopts a practical, hands-on, approach to learning, where all modules are fully assessed using continuous assessment methods. There is no formal end of semester written examination and this ensures students will learn by doing from the first module to the last. This 60-credit programme is delivered over two 30 credit semesters.

Objectives

Upon successful completion of the HDip graduates will have an expert knowledge on the methodologies to ensure quality validation and associated data analytics.

Course content: the course has a good mix of "hard" and "soft" skills ranging from technical content on specific aspects of Data Analytics, CSV etc to personal development skills associated with communication & leadership. It is essential that students engage in all aspects of this programme as module activity is cross-linked, e.g. the Professional Development and Communications module is essential for preparation towards the placement/project modules.

Entry Requirements

Open to graduates and experienced personnel with a Level 8 qualification in science, life science, business, engineering or related disciplines.
Applicants with a Level 7 in a Science/Engineering discipline AND extensive relevant industrial experience or training may be considered via the University’s recognition of prior learning (RPL) policy and process.

Long Description

The Higher Diploma in Quality Systems Validation with Data Analytics is a 60 credit, 12-month full-time programme. The course is industry focused, to address scientific skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & MedTech sectors. The HDip is designed with Industry to upskill graduates to become specialised in Validation and Quality Systems, with a strong data integrity focus.

Validation, Statistical Quality Control and Data Analytics are areas that have been identified where skilled graduates are needed. The regulatory and validation sections of the course provide an overview of the regulatory requirements for industry. This includes the requirements of regulatory bodies on validation of software systems used in industry and regulatory requirements on electronic records and signatures, Data Integrity and Quality Risk Management as applied to Computer Systems Validation. The programme places a strong emphasis on professional development, management and leadership skills, all of which will allow students to develop their career aspirations.

There has been substantial investment in the BioPharmaChem sector, enhancing the development of new skills from traditional small-molecule manufacturing. Increasing automation and advances in manufacturing processes from batch to continuous manufacturing is critical to creating the optimum manufacturing environment, utilizing skid technology and prioritizing innovation.

This programme is aimed at those wishing to transition in the latest developments in data analytics and validation, providing a strong talent pipeline for industry, combining knowledge, skills and expertise. There will be a strong data integrity focus, producing graduates with expert knowledge on the methodologies to ensure quality validation and associated data analytics. The HDip places significant emphasis on student learning. It adopts a practical, hands-on, approach to learning, where all modules are fully assessed using continuous assessment methods. There is no formal end of semester written examination and this ensures students will learn by doing from the first module to the last. This 60-credit programme is delivered over two 30 credit semesters.

Over 60% of the Department of Physical Sciences' graduates work in the regional BioPharmaChem & MedTech sector and as a result, the department has very strong linkage within
the regional industries where there are ongoing skills gaps for quality validation roles. The Department works closely with the University’s Careers Services in development of professional CVs for students, providing both on-line and one-to-one CV preparation techniques and workshops. Interview preparation and mock interviews are also part of
workshops delivered in conjunction with the Careers Services.

Why Choose This Course

The Higher Diploma in Quality Systems Validation with Data Analytics is a 60 credit, 12-month full-time programme. The course is industry focussed to address scientific skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & MedTech sectors. The HDip is designed with Industry to upskill graduates to become specialised in Validation and Quality Systems, with a strong data integrity focus. Higher Diploma in Quality Systems Validation with Data Analytics. Upon successful completion of the HDip graduates will
have an expert knowledge on the methodologies to ensure quality validation and associated data analytics.

Career Opportunities

Upon successful completion of the HDip graduates will have an expert knowledge on the methodologies to ensure quality validation and associated data analytics. There are many career opportunities for graduates in the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & MedTech sectors.

Timetable Info

Semester 1 (Sep-Dec):

Data Analytics & Chemometrics (5 credits)
Validation of Quality Systems (5 credits)
Quality Systems, LIMS and SQC (5 credits)
Regulatory Affairs & Auditing (5 credits)
Professional Development & Communications (5 credits)
Management and Leadership (5 credits)

Semester 2 (Jan-May):

Regulatory Industrial Placement (10 credits)
Experimental Industrial Project (20 credits)

Delivery Location

MTU Bishopstown Campus, Cork

Delivery Notes

The delivery mode will be blended, which means that lectures will be online, with tutorials and practical sessions on campus. This will of course be dependent again this year on Health and Safety requirements.

Placement/Project: Semester 2 comprises of a combined placement and project to be carried out in an industry or applied research setting. We are happy to consider applicants who wish to carry out this work at their current place of work, where relevant and possible. Our placement and project coordinators will work closely with applicants to place students in their desired roles and industry/research settings, where possible.

Admissions Contact Details
Contact Person

Admissions Office

Address

Munster Technological university, Bishopstown Campus, Cork

Phone

0214335040

Email

AdmissionsCork@mtu.ie

RPL Information

https://www.cit.ie/rpl

Application Procedures

It is essential that you check the eligibility requirements on the SB+ website before applying: https://springboardcourses.ie/eligibility. Our department will check applications to make sure that applicants meet the academic requirements whereas queries regarding eligibility are covered in the Q&A section at that web page. Note that applicants must have a minimum level 8 qualification. Applicants with a Level 7 in a Science/Engineering discipline AND extensive relevant industrial experience or training may be considered via the University’s recognition of prior learning (RPL) policy and process.

Apply online via www.springboardcourses.ie

Media
Physical Sciences Website

Physical Sciences Website

http://physicalsciences.cit.ie/qsvda