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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:

    Application Deadline: 30/8/2019 (Via Springboard+)

Admission Requirements:

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

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 crossskill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries.

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 in September 2019 (date to be confirmed) at the CIT Bishopstown Campus. Institute staff will be in attendance to offer career guidance and assistance.

 

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 continuous assessments (case studies project, practical and industrial visits) and formal exam assessments.


Award

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

 

 

 

 

 

Information for Students:

  • Email will be sent to students with information once the student has been accepted onto the course. Please check emails regularly.
  • Registration/induction – students can register in the Admissions Office in the Administrations Building (building 11 on CIT map) and receive their ID cards from the Card Centre (building 10 on CIT map) from 9am to 7pm (Monday to Thursday) and 9am to 4pm on Fridays until the 27th September. Students can use staff car parking area near the Student Center (building 10 on CIT map) after 5pm.

  • 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 (CIT’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.

  • Students have the opportunity to attend the Induction Session on Wednesday 18th September.

 

Induction date: Wednesday 18th September at 6pm. Venue: T101 (Tourism Building 12 on CIT map)

  • Introduction to CANVAS, myCIT email and web4student.
  • Introduction to the course and module for this semester 1.

 

Overview on using CANVAS and myCIT email:

 

Link to MAP of CIT:

 

Course Start Date: 25th September 6:00 - 8:00pm.

 

 

Workshop in UCC: A Day in the Life of A Validation Engineer. Presentations by Abvie, DPS, GSK, Janssen, LSC.

 

Venue: UCC-room number to be confirmed. Information will be emailed to the student’s myCIT email address.

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 which will be hosted in CIT and UCC, and there will be assessments to be completed on these workshops. Your attendance to these will be required. Information on these workshops (dates/venue/topic) are to be finalised.

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

 

Semester 2 (February to May) 13 weeks

 

  • Applications for this course are processed via Springboard+
     
  • This course open to all applicants; Employed, Unemployed, and Returners who meet the eligibility criteria at the time of course commencement.
     
  • 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.
     
  • Visit: Am I Eligible For a Springboard+ Course? at https://springboardcourses.ie/eligibility
     
  • The dedicated Springboard freephone helpline is available for further advice and information – 1800 303 523.

 

 

Elaine MCarthy / Tammy Browne
PET.Dept@cit.ie
021 4335150