Course overview
This course aims to introduce the strategy for producing high quality safe pharmaceutics. This course will focus on the traditional approaches to ensure product quality using facility design, validation and good manufacturing practice (GMP). Special reference will be made to the manufacture of biologics including antibiotics, therapeutic proteins and vaccines.
- Regulatory Affairs
- Validation
- Good Manufacturing Practice (Gmp)
- Facility Design
Course learning outcomes
- Identify the key events in the evolution of current regulation of pharmaceutical manufacturing
- Explain the role of the regulatory authorities (TGA, FDA, EMA, etc) in ensuring pharmaceutical product safety and efficacy
- Design a strategy to implement validation to pharmaceutical manufacturing and analytical techniques
- Design a strategy to implement Good Manufacturing Practice to pharmaceutical manufacturing
- Identify cleaning agents and describe the principles behind CIP and SIP to pharmaceutical manufacturing
- Design the layout of a pharmaceutical manufacturing facility
- Locate sources for regulatory guidance
- Write a report in a professional style
Degree list
The following degrees include this course