This course provides an introduction to types and growth of microbes, and methods of controlling microbial contamination as required in a Good Manufacturing Practice (GMP) environment.
Objectives
- Describe different types of micro-organisms that might be found in product, water and the environment
- Identify some major sources of microbial contamination and what is considered objectionable
- Identify microbial contamination problems in the workplace
- Identify some procedures that reduce the chance of microbial contamination
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- What do you think?
- What do the GMP rules state?
- Bioburden
- What do you think?
- What do the GMP rules state?
- Bacteria, fungi and viruses
- Spores
- Roles of bacteria and fungi
- Basic classification of bacteria
- Select true or false for each statement
- Microbial growth
- What do you think?
- What do the GMP rules state?
- Factors for microbial growth
- More on temperature
- More on pH
- How bacteria grow
- How fast bacteria multiply
- How bacteria die
- Equipment storage
- Optimal temperature
- Growth conditions
- Controlling micro-organisms
- What do you think?
- What do the GMP rules state?
- Ojectionable organisms
- Minimising microbes
- Starting materials
- Equipment
- Pharmaceutical water
- Biofilm
- Environment
- Personal hygiene
- Review questions
- Match the terms
- Conclusion
- Regulatory inspection findings
- Summary
Participants
This course is designed for induction of personnel new to GMP as well we refresher training for anybody with a role that in any way involves production/packaging operations, equipment or materials in GMP facilities.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
Duration
The course is expected to take approximately 1 hour.
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
