Core content developed by biochemists and engineers during the start-up of a pharmaceutical plant
This program was developed on-site by a team of biochemists and senior chemical engineers, working within an engineering consultancy during the start-up of a new pharmaceutical plant to fill in the regulatory, risk management, GAMP, qualification, and validation gaps in knowledge of its own scientists and technicians.
You will write a technical report
You will write a 3,000-word technical report about the systems needed to consistently manufacture safe medicines and devices for patients. This is fundamental knowledge for any professional working in this sector
You will complete 7 quality risk management (QRM) workshops
QRM tools are crucial in the pharmaceutical manufacturing industry. They allow companies to
- manage potential risks that could compromise the quality of drugs
- identify and prioritize risks, assess their potential impact on product quality
- build product quality into the manufacturing process
We will guide you through the step-by-step process of using the seven different QRM tools. This is a fundamental skill for any professional working in this sector and a key outcome of this program.
Minimum Entry Requirements
This program is highly specialized so you MUST have the following:
Ph.D., Masters, Degree or Higher Diploma in:
- Pharmacy
- Pharmacology
- Pharmaceutical science
- Food Science
- Food Technology
OR have worked in Quality Control or Quality Assurance in the following sectors:
- Medical devices
- Nutritional
- Beverage
- Dairy manufacturing
- Food science
AND YOU MUST
- currently work in the field
OR - have worked or graduated in this field within the last 2 years
If not, check out our University Certificate in eBioPharmaChem
If you have a quality background in engineering/manufacturing, check out our Conversion Course into Engineering Roles in Pharma.
