This Program is Right For You If;
Minimum Entry Requirements
This program is university accreditated by TU Dublin, Ireland so you need one of the following to meet its entry requirements:
- You have worked in a Good Manufacturing Practice (GMP) regulated manufacturing environment e.g:
- Pharmaceutical
- Medical device
- Nutritional
- Beverage
- Food
- Dairy manufacturing
- Or
- You have a sound understanding of GMP rules, regulations and guidelines.
Or - You have a relevant honours engineering degree or laboratory science degree and want to get a university certificate.
Or - You have successfully completed our Conversion Course into Pharma.
If you don’t meet our entry requirements, first take our Conversion Course into Pharma program.
This Certificate is Accredited by a World Top 4% University
What Roles Could I Retrain For?
STEP 1: Take this Level 7 “Certificate in BioPharmaChem” program. Typical roles we see advertised on our jobs board:
- Quality Assurance Specialist – Some companies call this role:
- Quality Assurance Associate
- Quality Assurance (QA) Technician
- QMS/QA Specialist
- Quality Systems Coordinator
- Documentation Specialist – Some companies call this role:
- Document Controller
- Documentation Coordinator
- Validation Technician – Some pharma companies call this role:
- Associate QA Validation Specialist
- Equipment Validation Specialist
- QA Validation Associate
- QA Validation Specialist
- CQV Engineer – Some pharma companies call this role:
- CQV Specialist
- C&Q Specialist
- C&Q Junior Project Manager
And with experience
Study all the Way to a Degree
STEP 2: Then you can take this “Certificate in Validation” program to move into more senior validation roles with a higher salary. Typical roles
- Senior Validation Technician
- CQV Technician
And with more work experience
- Validation Engineer
- Process Validation Engineer
- Cleaning Validation Engineer
STEP 3: If you have completed our Certificate in eBioPharmaChem and Certificate in Validation which are standalone programs, you are already halfway to a level 7 Degree. Take 6 more modules to get a BSc degree in Degree in Manufacture of Medicinal Products (DT 291)
What you’ll learn – There are four modules in this 37-week program
Module 1 – Fundamentals of Pharmaceutical Manufacturing Technologies (Weeks 1 -10)
This module will give you a broad understanding of how pharmaceutical products are made, the rules that govern manufacturing and the guidelines on how these rules are applied. You will also complete 7 different risk management tool workshops where you will learn to make extensive use of worst-case scenario planning to figure out what could go wrong in the manufacturing process and come up with steps to mitigate those risks. You will cover:
- Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems vs regulation vs validation.
- Quality Risk Management (QRM) – the huge importance of risk management and the steps involved in its application.
- GMPs vs Quality Management Systems – GMPs vs ISO 9001:2015 and why use them both.
- Industry Regulations and Guidelines – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
- Good Automated Manufacturing Practices (GAMP) – software categories, scalable validation deliverables, and operation activities.
- API Manufacturing Technologies – organic chemical synthesis, aseptic & sterile manufacturing, separation technologies, and multi-stage sequence API synthesis.
- Biopharmaceutical Manufacturing Technologies – upstream processing, fermentation cellular protein synthesis, downstream processing, and column chromatography.
- Process Validation and Documentation – design and verification of manufacturing systems
- Cleaning Validation – engineering and chemical aspects of cleaning and cleaning equipment
- Key Manufacturing Technologies – tablet manufacturing, vial filling, and freeze-drying FDA vs EU medical device regulations and classification.
- Equipment Validation – IQ OQ PQ and Baseline Guide 5.
Module 2 – Advanced Writing Skills (Weeks 11 -13)
This module will give you the written communications skills to properly write reports and reference and cite source material in a manner that is consistent with the professional norms of this industry. It will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry.
Module 3 – Commissioning & Qualification of Equipment and Systems (Weeks 14 – 25)
This module will explain the engineering documentation (P&IDs, piping isometrics, etc.) used to specify and design equipment or systems in a manufacturing facility and will also walk you through how to develop a 100-page plus validation test (IQ, OQ, PQ) protocol for a clean in place (CIP) system. You will learn:
- How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
- How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
- How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
- The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications).
- How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
- How to qualify equipment, instruments and piping systems, and automation controls.
- How to document all of these steps in a 100 page plus equipment validation protocol which you will develop as your end of module assignment.
Module 4 – Chemistry for API’s (Week 26 – 37))
This module will provide you with a foundation in the general chemistry necessary and fundamental concepts involved in the chemistry of API (Active Pharmaceutical Ingredients) required for the manufacture of medicinal products.
