Programme Highlights
No Science or Engineering Background Needed
This course is for people with no science, engineering or technical experience and will introduce you to the manufacturing of safe medicines and medical devices in a GMP (Good Manufacturing Practices) regulated environment.
Check that this well-paying industry is the right fit for you
Learn about the manufacturing technologies and the regulations which govern them to check that this well-paying industry is where you want to build your campaign
Build on this Initial Qualifications Further
Our Manufacturing Safe Medicines (Foundation) is the first step to getting a full BSc Degree and forms a potential pathway to join a rapidly expanding industry with huge job and career prospects
Learn from Experts at Your Own Pace
The module is written and taught by our Lecturer – Dr. Brady – and you can complete it from the comfort of your own home in an 8-week period
This Course is Right For You If;
- You want to pursue a career in pharmaceutical or medical device industry but don’t have an engineering, science, production, manufacturing or IT background.
- You want to get a basic understand of how pharmaceutical manufacturing works and familiarise yourself with the specialise concepts and terminology involved.
- You are looking for a stepping stone to our follow-on specialization in eValidation or eBioPharmaChem
This course is probably not for you, if
- You already have a background in manufacturing, food production, science or engineering.
How does Studying Online Work?
Hear From People Who’ve Taken This Course
Renato Chato
“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”
Michael Cheong Yim Poh
“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”
Your Lecturer
Dr. Joe Brady
Lecturer, Dublin Institute of Technology
Dr. Joe Brady is an assistant lecturer with the Dublin Institute of Technology (DIT), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer, and highly experienced in competency based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.
He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.
Your 10-Week Class Schedule
Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.
And he or she will proactively follow up with you to keep you on track.
Week 1 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 1
- Finished Medicinal Products
- Focus on Patient Safety and Product Quality
- ISO-9001 ‘Quality Management Systems — Requirements’
- Product Quality and cGMP Practices
Week 2 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 2
- Regulatory Guidelines for API Manufacturing
- ICH Q10 Continual Improvements
- Quality Systems Regulations – Manufacturing
- FDA Medical Device Rules
- Medical Device Regulations & Guidelines
Week 3 – Process Validation & Documentation
- Process Validation
- ASTM E2500 ‘Specification, Design & Verification of Manufacturing Systems’
- PQ, OQ and IQ (Performance Qualification, Operational Qualification, Installation Qualification)
- Cleaning Validation
Week 4 – Risk Management Tools for making Scientific Based Decisions
- Introduction to Quality Risk Management
- Fault Tree Analysis
- Failure Mode Effects Analysis (FMEA)
- Documenting the Quality Risk Management Process
Week 5 –Key Manufacturing Technologies – Part 1
- Batch Organic Chemical Synthesis
- Biopharmaceutical Manufacturing
Week 6 – Key Manufacturing Technologies – Part 2
- Tablet Manufacturing
- Aseptic & Sterile Manufacturing
Week 7 – Purified Water, Clean Steam & Cleaning
- Purified Water Generation, Storage & Distribution
- Clean Steam
- Water for Injection, Storage and Distribution
- Engineering Aspects of Cleaning
- Chemistry Aspects of Cleaning
- Steam Sterilization
Week 8 – Cleanrooms
- HVAC for Non-Sterile Manufacturing
- Cleanroom Layout
- Area Classification Protection
- Cleanroom Gowning
- Cleanroom Monitoring
Complete the Following Activities & Workshops
Engage in a series of activities during the course including:
- How and where to apply risk management techniques for making decisions
- Writing an Achievements Based CV
- Interviewing Effectively
Certified by GetReskilled
You will receive an end of course certificate from GetReskilled.
Price
S$499/month
For 2 Months
S$799 in Advance
Save S$199
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Contact Us
Singapore
Call Geraldine: +(65) 6513 9500