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45 - PHR - Pharmaceutical Sciences


PHR 107 - Pharmaceutical Microbiology Laboratory Training

Code Start Date Duration Venue
PHR 107 31 October 2022 5 Days Istanbul Registration Form Link
PHR 107 26 December 2022 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