Validation Science

  • Course Code

    CR_SVASC_7

  • Field of Study

    Biopharmaceutical,Pharmaceutical

  • Type of Course:

    Certificate

  • Type of Qualification:

    Certificate

  • Type of Study:

    Part time

  • Application Closing Date:

    26th August 2022

Course Summary

This Special Purpose Award in Validation Science provides an accredited 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. The course is delivered completely online with video recordings of online material content using MP4 videos and a number of industrial led workshops (pharmaceutical, biopharmaceutical and medical device industries). The course is assessed using online assessments and online submissions of assignments.

Admission Requirements:

Candidates are required to have a minimum of a Level 6 qualification (120 credits), or equivalent, in an engineering or science discipline.

Department(s)

Process, Energy and Transport Engineering

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

 

 

 

 

Overview

This Special Purpose Award has been developed in response to the requests from the industrial participants in the South Western Skills Forum.


The programme targets employment roles in production/ manufacturing, quality assurance, regulatory affairs, commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device manufacturing companies.


Students gain valuable knowledge and key skills in subject areas pertinent to working in highly regulated manufacturing environments such as GMP, QA, QC and Validation.


Students will attain a knowledge and understanding of the principles of quality regulation as required by the principles of current Good Manufacturing Practice. 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. The student will gain an understanding of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry. The proposed modules are focused not only on the biotechnological industries but also find applications into other regulatory compliant environments such as the pharmaceutical and medical technology sectors.

 

The programme uses a mixture of online multiple choice question assessments and online submission of assignments.


Award

Special Purpose Award - Certificate in Validation Science (10 ECTs) (Level 7 on the National Framework of Qualification)

 

Information for Students

  • Initial email will be sent to students personal email account with information once the student has been accepted onto the course.   


    Once registered, students will be sent an email to the personal email address with information on how to activate your myCIT email, how to access CANVAS (MTU Cork’s virtual learning platform) and web4student (your academic record). Your myCIT email address will be the mode of contact for information from the co-ordinator of the course. 


    Registration date to be confirmed.

Class Delivery

All material for this programme will be delivered completely online (lecture material, lecture recordings, assessments, assessment submissions, webinars and workshops).

 

An induction online class will be scheduled. An email with details will be sent to you and this information will be placed up on this website.

 

Material content will be scheduled for release in bulk amounts and it will be your responsible to review material and complete the online assessments.  Workshops will be scheduled for live online sessions presented by our industrial partners and online submission of assignments associated with these in term 1. The Webinars recorded by our industrial collaborators on relevant topics to industry will be released during the term.  

 

Overview on using CANVAS and myCIT email

 

Link to MAP of MTU Bishopstown Campus:

 

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.

 

The content covered and the assessment breakdown can be viewed by clicking on the links below.
 

The course consists of two 5 credit modules:

Semester 1 (September to December) 13 weeks

  • Introduction into Validation

     

    Introduction into Validation consists of 40 lessons (online videos) divided into 6 topic units with 6 assessments to be completed (10 Short Answer Questions answered online).
     
    There will be a number of workshops (4 max) delivered by industrial partners as live online classes which will be recorded and there will be assessments to be completed on these workshops (submitted online). Suggested dates for these Workshops for Term 1 includes (subject to change):

    Wed 28th Sept, 6:00 - 8:00pm. Introducing Validation Skills in Practice-A Day in the Life of A Validation specialist. Speakers: Abbvie, DPS, GSK, Janssen, LSC.


    Wed 12th October, 6:00 - 8:00pm.  Validation of Medical Devices Part 1,  Boston Scientific.


    Wed 2nd  Nov, 6:00-8:00pm. Quality Assurance Workshop,  Alcon.


    Wed 16th Nov, 6:00 - 8:00pm. Cleaning Validation Workshop. Abbvie, GSK


    There will be a number of Webinars from industry partners which will be available online.  
     

    All the online material will be made available to you over the duration of the term with scheduled deadlines of assessments and assignments to these workshops.

      

Semester 2 (February to May) 13 weeks

  • Validation Science


    Validation Science consists of 40 lessons (online videos) divided into 8 topic units with 2 assessments to be completed (Multiple Choice Questions answered online) plus project/assignment work.
     

    There will be a number of workshops (4 max) delivered by industrial partners as live online classes which will be recorded. Suggested dates for these Workshops for Term 12includes (subject to change):

     

    Wed 8th Feb, 6.00 - 8.00pm. Validation of a Purified Water Systems. Hovione.

    Wed 22nd Feb, 6.00 - 8.00pm. Validation of Medical Devices Part 2. Boston Scientific.

    Wed 8th March, 6.00 - 8.00pm. The Validation Lifecycle: Process Validation, Risk Management; Validation of Pharma/Biopharma. PM group.

    Wed 22nd March, 6.00 - 8.00pm. Cleaning Validation.  Janssen.


     

    There will be a number of Webinars from industry partners which will be available online.  
     

    All the online material will be made available to you over the duration of the term with scheduled deadlines of assessments and one report assignment.

 

 


 

Springboard+

Application Procedure

Springboard+ courses are free for people who are unemployed, those who were previously self-employed and returners to the workforce. Courses at NFQ Level 6 are also free for those in employment.

For employed participants on courses NFQ level 7 – 9, 90% of the course fee is funded by the Government, with participants required to contribute just 10% of the fee.

 

  • This course is Springboard funded – apply via springboard  https://springboardcourses.ie/details/10459
  • This course open to all applicants; Employed, Unemployed, and Returners who meet the eligibility criteria at the time of course commencement.
  • Closing date for application is 26th August 2022.
     
  • Documentation supporting applicant’s status will be required as part of the application process.
     
  • Further proof confirming an applicant’s continued eligibility will also be required at the time of course commencement.
     
  • This course is Springboard+ funded. Check availability and visit: Am I Eligible For a Springboard+ Course? 
     
  • The dedicated Springboard freephone helpline is available for further advice and information – 1800 303 523.

 

Elaine MCarthy / Tammy Browne, PET Department Secretaries
Cert.ValScienceCork@mtu.ie
021 4335150

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