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5. PF6037: Digital Transformation and Novel Products in the (Bio)pharma Industry

Course Fact File

Code	PF6037
Duration	12 weeks
Teaching Mode	Part-Time. See Additional Teaching Mode Information for more info.
NFQ Level	Level 9
Fees	€2,500 - HCI Subsidy Initiative See Fees and Costs for full details.
Closing Date	Currently closed for applications
Venue	Blended delivery.
Credits	10
Start Date	Currently closed for applications

Outline

Module Goal

Provide an introduction to industry 4.0 and how the principles of industry 4.0 have been applied to the (bio)pharmaceutical industry and specifically process control.Provide an introduction to novel and advanced medicinal products such as combination products and their manufacture.

Module Content 

• Process Control in biopharma manufacturing via automation
• Data management systems in biopharma
• Industry 4.0 and its application biopharma manufacturing i.e., Pharma 4.0
• Digitisation and digitalisation of processes within the biopharma manufacturing environment
• Rapid Micro Methods and digital advances in QC analysis
• Achieving Real time release
• Computational Fluid Dynamics and Modelling in biopharma
• Role of machine learning, artificial intelligence, in the future of biopharma
• Introduction to marketed biopharmaceutical combination devices such as pre-filled syringes, auto-injectors, inhalers and antibody-drug conjugates
• Material and physical science of primary and secondary packaging of biopharmaceuticals
• Manufacturing considerations for combination products
• Device design and verification including human factor studies
• Design History File
• Regulatory requirements around combination devices (EU MDR, 21CFR820 etc.)
• Next generation digital Combination devices
• Cell and Gene Therapies

Additional Teaching Mode Information

• 10 x 3 hr(s) workshops

Practicalities

Continuous Assessment - 200 marks

• Assignment - 2,000 word written assignment (100 marks)
• Presentation (100 marks)

Why Choose

On successful completion of this module, students should be able to:

1. Describe Industry 4.0 and how it applies to the biopharma industry i.e., Pharma 4.0 including the adoption of PAT.

2. Differentiate between data, information and knowledge.

3. Compare and contrast the different automation and control systems found in industry (DCS, Scada, HMI, PLC etc.) and how they complement the process control strategy.

4. Compare and contrast the various types of data models in industry and evaluate their utility in a GMP environment.

5. Differentiate novel and advanced medicinal products including their mode of action, manufacture and regulatory requirements.

6. Appraise the design and verification requirements for a combination product and how these are managed in a Design history file.

Requirements

Applicants must have at least

• Second Class Honours Grade 2 in a primary honours’ degree (NFQ, Level 8) in any of the following relevant subject areas: chemistry, biology, biochemistry, physiology, pharmacy, pharmaceutical sciences or science, healthcare science, technology, or process engineering. Eligible applicants may also be invited for an interview.
  • Selection from among eligible applicants will be made according to the following criteria: 
    • Performance in their primary degree
    • Personal statement
    • Consideration under Recognition of Prior Learning (RPL) may also be given to applicants who do not meet the above entry requirements but who have relevant professional experience in a suitable field. To demonstrate relevant professional experience, applicants will be assessed on the following criteria and an interview may also be required. 
      1. Academic achievement
      2. Relevant industry experience
      3. Personal statement
      4. Reference

Fees and Costs

The HCI Pillar 3 Micro-credential Learner Fee Subsidy has been introduced to enable more learners to address critical skills gaps and engage with lifelong learning.

The fee for this micro-credential is €2,500 but applicants who meet the subsidy requirements can attend this micro-credential for €1250.

Check your eligibility on the HEA Website

How To Apply