This module will give you a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied along with the risk management tools to be used when making decisions that could impact the safety of the medicines being manufactured.

Week 1 – Manufacturing Safe Medicines
Week 2 – GMP’s and Quality Management Systems
Week 3 – Good Automated Manufacturing Practices (GAMP)
Week 4 – API Manufacturing Technologies
Week 5 – Biopharmaceutical Manufacturing Technologies
Week 6 – Cleaning Validation
Week 7 – Medical Devices and Sterile Manufacturing
Week 8 – PQ OQ IQ
Week 9 & 10 – Complete an End of Module Assignment. Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.

This program explains the engineering documentation used to specify and design equipment or systems in a manufacturing facility – and how to develop the test protocols (IQ, OQ, PQ) to ensure that it operates as intended and meets the regulatory requirements.

Week 11 – Interpreting P&ID’s
Week 12 – System Impact Assessment & Traceability Matrix
Week 13 – Installation Tests & Equipment Verification
Week 14 – Piping Isometrics & Checksheets
Week 15 – Instrument Loops & Checksheets
Week 16 – URS & Functional Testing
Week 17 – Assembling the Validation Protocol
Week 18 – Validation Protocol Final Review
Week 19 & 20 – Complete an End of Module Assignment. Write an IQ OQ PQ protocol for a Clean-in-Place system.

The aim of this module is to provide a foundation in the general chemistry necessary to appreciate the fundamental concepts involved in the chemistry of API (Active Pharmaceutical Ingredients) required for the manufacture of medicinal products.

Theory
Week 21 – Chemistry and Matter; Atomic Theory
Week 22 – The Periodic Table and Bonding
Week 23 – Stoichiometry
Week 24 – Acids and Bases Recrystallisation
Week 25 – Introduction to Organic Chemistry

Practical Laboratory
You will need to complete a full day laboratory during the remaining 5 weeks of the module. We will release preparatory material before the lab for you to study, review and print out.

NOTE: Labs are always held on Saturdays at the Dublin Institute of Technology. Special arrangements will be made for non-Irish residents.

Week 26 – Release & Review Materials ahead of Attending Laboratories
Introduction to Practical Chemistry
Materials for Laboratory Part 1 – Synthesis of Aspirin
Materials for Laboratory Part 2 – Organic Compound
Materials for Laboratory Part 3 – Calculations
Materials for Laboratory Part 4 – Preparation of Sodium Carbonate for washing soda using Titration

Week’s 27 – 30+ Attending Laboratory and Completion of an Online Exam

Add On Program – 5-Week Advanced Career Coaching
Open Your Eyes to Modern Job Hunting

This is a practical course, not a theoretical one. There is no “filler” content. Each and every task is specially designed to take you one step closer to the job you want in a structured way.

The course is assessed using a mock application for a real job advert. You’ll complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques.

“I never realised how much I didn’t know”

That’s the most common feedback we get when people finish this programme. And it really doesn’t take that long to get that new knowledge and start putting it to good use…

Week 1 – Get a comprehensive understanding of BioPharma/MedTech Industry and figure out jobs you can do
Week 2 – Practice skills assessments, write, rewrite and customize CVs and resumes
Week 3 – Speculative job applications and how to research jobs available
Week 4 – Social Media, networking and interview preparation
Week 5 – End of Module assignment. Complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques.

On completion of this module you’ll be able to:

1. Discuss your local BioPharma/MedTech manufacturing industry
2. List the departments and job roles where your skills are best suited
3. Understand your current skill set and how to discuss that with employers
4. Network effectively both on and offline
5. Write a CV and cover letter that are highly tailored to a job advert
6. Write a speculative application and have a list of local companies appropriate for such an application
7. Prepare for an interview

You’ll also have access to a program advisor who is there to offer support and guidance, offer personalized feedback and provide additional resources in any areas you need a little extra help.

At the end of the course, you’ll have confidence through a more strategic approach to job hunting. You’ll have a complete tool kit for modern job hunting.