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45 - PHR - Pharmaceutical Sciences
PHR 107 - Pharmaceutical Microbiology Laboratory Training
| Code | Start Date | Duration | Venue | |
|---|---|---|---|---|
| PHR 107 | 25 September 2023 | 5 Days | Istanbul | Registration Form Link |
| PHR 107 | 20 November 2023 | 5 Days | Istanbul | Registration Form Link |
| PHR 107 | 11 December 2023 | 5 Days | Istanbul | Registration Form Link |
Please contact us for fees
Course Description
In order to ensure patients safety and preserve the quality of the material, laboratory personnel need to understand the role that pharmaceutical microbiology play. They have to be aware of quality control issues, method development, process and product design, and product stability. This course offers some standardized test methodologies, the way to validate these test methods and a guide to the international practices in Pharmaceutical microbiology laboratories adopted by WHO. Participants are expected to gain a significant operational knowledge needed to be present in laboratory practitioners and significant operational capabilities of the laboratory itself.
Course Objectives
- Experimenting the test methods for finished Pharmaceutical Products
- Learning the validation procedures
- Estimating the uncertainty in these methods
- Experimenting the rapid microbiological test methods
- Learning the good laboratory practices adopted by WHO
Who Should Attend?
- Research and development persons
- Pharmaceutical formulation and production engineers and pharmacist
- Quality control chemists and pharmacist
Course Details/Schedule
Day 1
- Test methods for finished Pharmaceutical products:
- Microbial Limit Test
- Sterility Test
- BET
- Efficacy of Antimicrobial Preservation
- Potency test for antibiotics products
Day 2
- Validation tests methods
- Selection of Methods
- Laboratory Developed Methods
- Non-standard Methods
- Validation of Methods
- Methods Requiring Validation
- Process
Day 3
- Estimation of Uncertainty of Measurement
- Procedure for Calibration Activities
- Procedure for Testing Activities
- Uncertainty Components
- Control of Data
- Data Transfers
- Computer use
Day 4
- Rapid microbiological test methods
- Growth-based
- Viability-based
- Cellular Component-based
- Optical Spectroscopy
- Nucleic Acid Amplification
- Micro-Electrical-Mechanical Systems (MEMS)
- Validation of these methods
Day 5
- Good laboratory practices (GLP) in pharmaceutical microbiology laboratories
- Personnel
- Environment
- Equipment
- Reagents
- Labelling
- Organism resuscitation
- Sample handling
- Disposition of contaminated waist
- Test reports
