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

Munster Technological University Cork (Quality Systems)
Key Programme Details
Award

Higher Diploma

NFQ Level

8 About NFQ

Delivery Method

Online

Mode

Full Time

ECTS Credits

60

General Information
Contact

Donagh O'Mahony

Email

donagh.omahony@mtu.ie

Phone

021 433 5595

Address

Bishopstown , Cork

Role

Course owner

Important Dates
Application Deadline

17/10/2021

Start Date

18/10/2021

End Date

30/06/2022

About this Course

This Higher Diploma for the BioPharmaChem industry is a 12-month full-time programme developed to address skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & Healthcare sectors.

Validation, Statistical Quality Control and Data Analytics are areas that have been identified where skilled graduates are needed. Companies ensure their processes are accredited, under the criteria laid down by ISO, INAB, ICH along with regulatory bodies (FDA, EMA, HPRA etc). Within these standards, validation is a prerequisite to acquire accreditation. Validation has been recognized as a discipline within industrial quality management systems departments therefore trained staff in this discipline is a necessity.
There has been substantial investment (< €4 billion) in the BioPharma Chem sector, enhancing the development of new skills from traditional small-molecule manufacturing. 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 regulatory and validation sections of the course provide an overview of the ISO, INAB, FDA and European 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.

The Department would like to offer this course for 3 cohorts over 3 years.

Objectives

To upskill graduates in areas of Quality Systems Validation for the advanced manufacturing sector, namely BioPharmaChem, Food and Beverage, MedTech, etc

Course content: the course has a good mix of "Hard" and "soft" skills ranging from technical content on specific aspects of analytical chemistry, instrument validation, etc to personal development skills associated with communication, leadership, etc. 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.
Students may avail of RPL if they can illustrate through portfolio and certification, that they have completed a previous course and reached the learning outcomes of a particular module in this Level 8 HD.

Long Description

This Higher Diploma for the BioPharmaChem industry is a 12-month full-time programme developed to address skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & Healthcare sectors.

Validation, Statistical Quality Control and Data Analytics are areas that have been identified where skilled graduates are needed. Companies ensure their processes are accredited, under the criteria laid down by ISO, INAB, ICH along with regulatory bodies (FDA, EMA, HPRA etc). Within these standards, validation is a prerequisite to acquire accreditation. Validation has been recognized as a discipline within industrial quality management systems departments therefore trained staff in this discipline is a necessity.
There has been substantial investment (< €4 billion) in the BioPharma Chem sector, enhancing the development of new skills from traditional small-molecule manufacturing. 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 regulatory and validation sections of the course provide an overview of the ISO, INAB, FDA and European 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.

The Department would like to offer this course for 3 cohorts over 3 years.

Timetable Info

Semester 1 (Sep-Dec 2021):

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

Semester 2 (Jan-May 2022):

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

Delivery Location

Taught modules will be delivered online

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 endeavour to place students in their desired roles and industry/research settings, where possible.

Delivery Notes

Delivery Mode: The delivery mode will be blended, which means that lectures will be online - for the most part - with tutorials and practical sessions on campus. This will of course be dependent again this year on Health and Safety requirements but we are planning for one half day (4 hours) per week on campus with additional delivery over two evenings per week. For the final semester, learners will be located in an industrial or research lab setting to complete their placement/project work.

Admissions Contact Details
Address

Munster Technological university, Bishopstown Campus, Cork

Phone

0214335040

Email

admissions@cit.ie

RPL Information

https://www.cit.ie/rpl

Application Procedures

apply online through www.springboardcourses.ie

Eligibility:
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.

Media
Department of Physical Sciences Website

https://physicalsciences.cit.ie/hci-free-and-subsidised-skills