Training
A two-day deep dive into pharmaceutical microbiology, from fundamentals to quality control methods, validations, and results interpretation.
In the manufacture of medicinal products and medical devices, quality assurance is inseparable from a quality policy that rules out the risk of microbiological contamination. Requirements around the absence of micro-organisms apply to virtually all medicinal products and medical devices. During production, it's not just the microbiological quality of the finished product that matters, the presence of micro-organisms in systems and processes is continuously monitored as well. This training contributes to safeguarding microbiological product quality.
In this course, participants will build and/or refresh their foundational knowledge of pharmaceutical microbiology. The focus is on a thorough explanation of the microbiological quality control methods and validations used within the (bio)pharmaceutical industry, along with deviations, troubleshooting, and interpretation of results.
Introduction to basic (bio)pharmaceutical microbiology
- History
- Classification and taxonomy
- Morphology
- Properties
Pharmaceutical microbiologyPharmaceutical microbiological testing (incl. suitability testing and troubleshooting)
- Bioburden determination
- Testing for specific micro-organisms
- Sterility testing
- Identification of micro-organisms
- Endotoxin determination
- Environmental monitoring (EM)
Microbiological validations
- Method validation and implementation
- Media fill
- Biological indicators
- Disinfectant efficacy testing
Microbiological results
- Interpretation of microbiological test results
- Handling deviations, Out of Specification (OOS), and Out of Trend (OOT) results
- Workshops
Employees of microbiological laboratories, Quality Assurance (QA), and Quality Systems (QS) staff involved in monitoring and assessing the microbiological quality of processes, systems, and products.
Practical information
Duration: Two days
Certificate: Certificate of completion
Price: €1,275 per participant
Price excludes VAT, includes course materials, coffee, tea, soft drinks, and lunch.
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