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  • Location

    Galway

    Waterford

    Athlone

  • Duration

    9 Months

  • Level

    Certificate

Course overview

Certificate Pharmaceutical & Medical Devices Operations

This course consists of a series of scientific, technological, quality, improvement and personal development modules designed and delivered by highly experienced tutors. Practical modules will be provided through the use of the Technological University Dublin, Tallaght Campus pilot facilities.

Learning and support will be provided through the use of the online portal Moodle. Participants who were unable to attend a particular module can obtain the information online if required. Participants who return to work during the course can avail of the online option to complete the lectures and sit the final exams. Extensive Coaching & Mentorship workshops will be provided with a specific focus on individual assessment and improvement.

Please note the following start dates:

Dublin, Cork & Limerick locations start September 2019

Waterford, Athlone & Galway locations start January 2020

 

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Course Outline

The course duration is 9 months. Lectures will be delivered 2 evenings per week online. Students will also be required to attend 2 Saturday's a month on campus in Dublin, Limerick & Cork.

Module 1: Pharmaceutical Science

Pharmaceutical dosage forms; drug product formulation and their chemical function; unit operations in pharmaceutical manufacturing processes; prepare granulates, formulate tablets, and analyse final formulations; types of packaging, closure systems and tamper evident seals and labels used for a product.

Module 2: Facilities / Utilities Management

Understand the fundaments of Facilities / Utilities Management, Heating Ventilation and Air Conditioning (HVAC), Review Pharmaceutical Water Systems, Aseptic Processing, Cleanroom Technology, Clean In Place (CIP) technology and validation of CIP and Understand Isolation technologies, Sterilisation Methods and Sterility testing

Module 3: Quality Control and Good Manufacturing Practices

The agencies which regulate healthcare manufacturing; management of regulatory documentation; the principles of Validation; the QC testing pathway; QC specifications of ingredients, components and products.

Module 4: Quality Assurance & GMP

Regulatory requirements for pharmaceutical manufacturing; documented procedures, Standard operating procedures, Batch manufacturing records; the role of audits, corrective actions and change control; the role and function of Quality Control and Quality Assurance; the role of the employee in delivering products; Interpretation and use of quality specifications.

Module 5: Medical Device Operations

Medical interventions and treatments provided to patients; operation of a medical device manufacturing facility; Good Manufacturing Practices and Quality Systems in medical device manufacturing; manufacturing processes and standards used during the processing of medical device products.

Module 6: Manufacturing Process Technology 

The steps normally used in a typical drug development process from discovery to market; the organisation of a  pharmaceutical plant and the functions of each department; the synthesis and purification of chemicals on a large scale; the equipment used in a bulk pharmaceutical plant and its operation; Waste treatment plant; record data during the manufacturing process.

Module 7: Professional Development for STEM

The importance of networking in today’s society; develop a personal carer plan; Write an appropriate CV that provides an outline of academic and employment experience; techniques and behaviours required to successfully succeed a job interview.

Module 8: Learning to Learn

Personal Strengths and weaknesses as a learner, set specific learning goals and create a personal learning plan; Study effectively as an independent learner and work collaboratively as a member of a team; Manage time efficiently with regard to planning and organising learning tasks; Use critical thinking and analytical skills to solve a variety of problems; Write a research-based report and make an effective presentation; importance of academic integrity and identify ways of avoiding plagiarism in academic work through appropriate referencing.


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Entry Requirements

This course is suitable for those with a minimum qualification at NFQ Level 5 or Leaving Certificate with five passes to include English and a Science subject. Mature students with relevant industrial experience are also eligible. All applicants must have competency in spoken and written English.

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Career Options

With the continued growth of the Pharmaceutical and Medical Device industry in Ireland, this course is suitable for those who wish to upskill to gain either

  • An entry level position within the Pharma/Medical Device Industries, or
  • Supplement their existing core skills to pursue a similar role within the Pharma/Medical Device Industries (e.g. Finance, HR, IT etc.,)

Possible Pharmaceutical and Medical Device roles you could fill post completion of this course include Product Design and Development, Injection Moulding, Continuous Improvement, Equipment Maintenance Technician, Quality Control/Assurance, Packaging, Project Engineering, Validation Engineering, Manufacturing Technicians, Automation/Robotic/VIsion Systems, Software Development and Support Services. 

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Apply Now

Our admissions team are on hand to assist you with your application and answer any questions you may have on the course.

Students who wish to apply to this course should follow the following application process. They should have obtained a Level 5 in Science, Engineering or a related discipline or Leaving Certificate Qualification.

First of all, you will need to complete and submit an enquiry form, located on the top of this page. This is to register interest with us in the chosen course. Once submitted a member of the team will be in contact with you via phone call or email to discuss the course in more detail, assess your eligibility and assist you with anything you need to progress further.

Subject to eligibility, the next step is too to fill out and submit the application form which will require you to submit the following documentation

  • A copy of your CV
  • Copy of a Government issued ID (passport or driver’s licence)
  • Transcript of your previous highest qualification.

We accept scanned documents in a pdf format. Pictures of documents are not accepted.

Following the submission of your application form, a member of our team will be in contact with you.

Please note through the application process if you have any questions please do not hesitate to contact us by email on admissions@innopharmalabs.com or call us (01) 485 3346

Why up-skill for the pharmaceutical industry in Ireland?

  • €3 billion in new capital investment
  • €39 billion in exports
  • Over 55,000 employed
  • 9 of top 10 world’s biopharma companies in Ireland
  • 12 of the top-selling drugs made in Ireland
  • Over 8,000 new jobs predicted by 2020
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Testimonials

Testimonials

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The lectures all come from the industry so they know what the Pharmaceutical companies are looking for

Laura McCarthy, ERP Automation Admin at Pfizer Certificate in Pharmaceutical & Medical Device Operations Graduate

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