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5. PF6041: Contamination Control for the Pharma and Biopharma Industry

Course Fact File

Code	PF6041
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	08/08/2024
Venue	Blended delivery.
Credits	10
Start Date	09/09/2024

Outline

Module Goal

To provide students with an introduction to contamination control strategies in the pharmaceutical and biopharmaceutical industries in line with EU Annex 1 regulations.

Module Content

• Contamination Control overview
• Regulatory Requirements for aseptic/sterile processing including EU Annex 1 revision
• Quality risk management application in contamination control strategy
• Contamination sources across the pharmaceutical supply chain and lifecycle
• Contamination control strategy
• Open and closed processing with focus on single use technology
• Cleaning & sterilization
• FDA warning letters review

Additional Teaching Mode Information

• 5 x 7 hr(s) workshops
• 15 x 1 hr(s) lectures

40 hr(s) directed learning

Practicalities

Continuous Assessment - 200 marks

• In-class test (MCQ) - 3 in class MCQs (120 marks)
• Presentation (120 marks)

Why Choose

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

1. Demonstrate applicability of contamination control across non-sterile, sterile and ATMP products

2. Analyse industry trends and best practices for contamination control

3. Demonstrate practical examples of contamination failures and identify potential root causes and preventative actions

4. Discuss the generation of a Contamination Control Strategy

5. Communicate the quality and regulatory requirements for contamination control making reference to EU Annex 1

6. Demonstrate how Supply Chain, QC, Engineering, Production behaviours impact contamination control.

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

Please select the following options during your online application (once you have created your profile)

 

Start a new Micro-credentials application by selecting as below

In the application level tab select the College of Medicine and Health, and then select the programme/module you'd like to apply for

Apply Now