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Good Manufacturing Practice & Technology Part-time (BSc)

  • Course Code

    CR_SGMPE_7

  • Field of Study

    Good Manufacturing Practice

  • Type of Course:

    Degree

  • Type of Qualification:

    BSc

  • Type of Study:

    Part time

  • Application Closing Date:

Admission Requirements:

Candidates are required to have a Higher Certificate or higher in an Engineering or Science Discipline (minimum 120 credits).  It is required that all qualifying candidates have completed modules in basic chemistry and biology (Level 6), and have a knowledge of GMP, to undertake the complete programme. A Level 6 mathematics module must be part of the qualification.


There are two routes of entry into this BSc course: Direct Entry and Advanced Entry.


Direct Entry to the BSc in GMP & Technology

Students must meet the above admission requirements.

Advanced Entry to the BSc in GMP & Technology

This route was developed for individuals who have relevant industrial experience seeking to gain a Bachelor of Science degree.

Students complete a technical portfolio which must be approved for entry into the BSc. The recognition of Prior Learning assists the students in the preparation of this. Information and booking of appointments are available on this website link: rpl.

The technical portfolio must prove evidence to support the completion of:

  1. Leaving Certificate Grade O6/H7 (pre. 2017, Grade D3 Ordinary Level) in five subjects. The five subjects must include English or Irish, and Mathematics.
  2. Five years or more relevant work experience in the pharmaceutical, biopharmaceutical, medical device or food industry. To prove the relevance of their application the candidate will need to show that they are familiar with the topics covered in the following modules (click on the modules for content):
     
    a. MANU6011
    b. STAT6008 
    c. MANU6013
    d. BIOM6003
    e. MGMT6021
    f. INFO6017 
    g. BIOM6004
    h. MATH6000

    Calibration Science
    Lean Manufacturing
    Manufacturing Technology
    Cleanroom Management
    GMP1/QA
    Information Technology
    Contamination Control
    Essential Maths Skills

     

  3. Special Purpose Award in the Certificate in the Science of Biotechnological Manufacturing Operations or equivalent.

Course summary

A nationally accredited degree designed to meet the education and training needs of supervisors and higher technicians in the areas of Production, Quality Assurance and Validation in the Pharmaceutical, Biopharmaceutical, Chemical and Medical Device Industries. The programme comprises of 11 modules and a Project. To complete the programme, each student must take the 7 mandatory modules and 3 elective modules, as well as the project. A maximum of one free choice elective may be chosen. The project is undertaken towards the end of the degree programme, when the student has successfully completed seven of the modules. The programme can be taken over 2 years or spread out over 3 or more years. There is a considerable element of continuous assessment. Laboratory experiments are included in appropriate modules.

Department(s)

Process, Energy and Transport Engineering

All part-time programmes at CIT will run subject to sufficient student numbers. Where a programme cannot proceed, applicants will be contacted and advised on alternative study options.

An Information session will take place on Wednesday 4th September 2019 from 5.30pm to 7.00pm at the CIT Bishopstown Campus. Institute staff will be in attendance to offer career guidance and assistance.

Students should note that Fees quoted relate to the academic year 2019-2020 only and are subject to change on an annual basis. Except where stated, course fees cover the cost of tuition only.

For more information on Fees, please visit fees/students


To download course brochure, please click here

Course Fee: €500 per 5 credit module
 

Exemptions

Applicants who have appropriate experience and knowledge of the Pharmaceutical, Biopharmaceutical, Medical Device, and Food Industries may be considered exempt from examination of some modules upon providing evidence via the Recognition of Prior Learning (RPL) scheme of the Institute.

Indicative Content
  • Validation Science
  • Manufacturing Operations
  • Chemical Applications
  • Technology Transfer
  • Maintenance, Utilities and Facilities
  • Biopharmaceutical Upstream
  • People Management
  • Process Improvement
  • Biopharmaceutical Downstream
  • Energy Management
  • Project
  • Formulation
  • Food Processing Technology
  • Introduction to Biomedical Devices
  • Biomedical Manufacture


Note: The running of individual modules will be dependent on a sufficient number of students enrolling on the course.
 

Award

On successful completion of the full programme of study: Bachelor of Science in Good Manufacturing Practice & Technology (Level 7 on the National Framework of Qualifications).
 

Frequently Asked Questions

How much does it cost, and how is the course delivered?
€500 per 5 credit module. Part-time, one module per night 6.30pm - 9.30pm. There is a considerable element of continuous assessment. Laboratory experiments are included in appro-priate modules.


On completion of this course, what are the career opportunities?
Examples of career roles include: Quality Assurance Specialist; Process Technician; Environmental Chemist; Validation Engineer; Manufacturing Support; Commissioning Qualification Specialist; and Quality Technician.


What if I have not completed  basic chemistry and biology modules (Level 6)?
CIT offers a Special Purpose Award in the Certificate in Science of Biotechnological Manufacturing Operations . The Science of Biotechnological Manufacturing Operations consists of two modules: Chemical Principles (Semester 1) and Introduction to Industrial Biotechnology (Semester 2). Delivery of this course is subject to numbers.

 

What if I do not have a maths module (Level 6) completed?
CIT offers a mathematics module (Level 6) in both semesters by evening which can be completed.

MATH6012 is delivered in Semester 1 (Tuesday 6pm - 8pm) and

MATH6051 (Thursday 6pm - 8pm ). Note: the schedule of these maths module may change. Information regarding these mathematics module will be confirmed on the website in September.

 

What technical documents are required for the direct entry route?
Certificates to prove completion of qualifications (National Framework of Qualifications).

 

How are the technical documents submitted?
Uploaded as part of the online application

 

What technical documents must be included in the portfolio for the advanced entry route?

Certificates to prove completion of qualifications (National Framework of Qualifications), training certificates of courses completed, letters of recommendation from supervisors which outline role descriptions, Curriculum Vitae (CV). Documents that support and outline the professional experience which meet the admission requirements. Note that these documents will be verified.

 

How is the technical portfolio submitted?
Uploaded as part of the online application.

 

What support exists for preparing the technical portfolio for the Advance entry route?
The Recognition of Prior Learning Office assists the students in the preparation of the portfolio.  Information on the RPL office and booking of appointments are all on the this website link

 

Which modules are delivered each term?
Information on modules delivered each semester for the coming year can be viewed on the website (course/CRSGMPE7

 

Graduate Profiles

“The practical aspect of the course concentrated on techniques that could be directly applied to industrial laboratories and pharmaceutical activities. The course allowed everyone to bring their own experiences and this combined with the detailed and informative lectures enabled the group to enhance their technical knowledge. The experience and knowledge I gained as a result of completing this course has allowed my career in QA to take a different direction and I am now the QA technical expert for the engineering department, and am involved in commissioning, validation, process improvement and problem solving.”
Audrey Kelleher

 

“I am one of many students to benefit personally from attending CIT. I was made redundant in 2009 with a maintenance background. This course allowed me the opportunity to up-skill and gain the knowledge and qualifications necessary to secure employment in the pharmaceutical sector. I am now employed as a Maintenance Technician at Janssen Biologics, Cork, and I feel that this assistance and support I received and the specifically designed courses greatly enhanced my re-employment prospects.”
Stephen O'Shea

 

"Having worked as a Health and Safety Professional in the pharmaceutical industry for over 19 years, Good Manufacturing Practices and Re-Validation were commonly seen as an obstacle to changing work practices to improve Health and Safety. This course through its broad subject range has greatly improved my knowledge of GMP, Technology Transfer, Validation Practices, Process Technology and Lean Six Sigma and has given me the ability to ensure that I also consider Quality Risk as part of my Health and Safety risk reduction methods in the workplace."
Toni O'Sullivan

"I am an employee of Boston Scientific Cork. For the first 8 years, I worked as a product builder, involved in routine production and also taking part in continuous improvement projects.  I am a current student of the BSc in GMP & Technology and recently I have been promoted to the role of Labelling Technician.  The practical skills I gained while working on the production line, backed by academic knowledge, have given me the confidence to pursue a career within the medical device industry." 
Geraldine Simms              

 

For detailed module information, please click here.

Note: The running of individual modules will be dependent on a sufficient number of students enrolling on the course. The module may be withdrawn if this requirement is not fulfilled.

Course Content

 

To commence September 2019 (One module per night from 6.30pm - 9.30pm)

  • Process Improvement (Mandatory)
  • People Management (Mandatory)
  • Biopharmaceutical Upstream (Elective)
  • Free Choice Elective (Elective)

To commence January 2020 (One module per night from 6.30pm - 9.30pm)

  • Manufacturing Operations (Mandatory)

  • Biopharmaceutical Downstream (Elective)

  • Biomedical Manufacturing (Elective)

  • Project (Mandatory)*

* Project can be undertaken once seven taught modules have been successfully completed.

Examples of career roles include:

  • Quality Assurance Specialist
  • Process Technician
  • Environmental Chemist
  • Validation Engineer
  • Manufacturing Support
  • Commissioning Qualification Specialist
  • Quality Technician
  • Online application will open shortly for course commencing in September 2019.
  • Note: The running of individual modules will be dependent on a sufficient number of students enrolling on the course. The module may be withdrawn if this requirement is not fulfilled.
  • Please note that applicants will be required to pay an acceptance fee of €500 online if a place on a course is offered. This fee is deductible from the overall course fee.

    Note: You will not be charged for applying for the programme by clicking the 'apply now' button, you are only asked to pay an acceptance fee if a place is offered to you and you wish to accept it.

  • Please attach and upload any documents such as transcripts, CV, other details relevant to the application.

 

 

 

 

 

 

 

 

Elaine MCarthy / Tammy Browne
PET.Dept@cit.ie
021 433 5150