CEU Credits: 0.1
Course Code: ELM-706
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
1 min 10 secs
Learning objectives
58 secs
Who should take this course?
1 min 23 secs
Terms explained
1 min 42 secs
Course modules
1 min 10 secs
Microbiological culture media
1 min 05 secs
Microbiological culture media
1 min 08 secs
Other culture media
1 min 10 secs
Microbiological examination of non-sterile products
1 min 09 secs
Test methods
1 min 11 secs
Microbial enumeration test (MET)
1 min 13 secs
Tests for specified microorganisms
1 min 02 secs
Acceptance criteria for non-sterile pharmaceutical products
58 secs
Microbial examination of sterile products – Endotoxin test
1 min 10 secs
Microbial examination of sterile products – LAL Test
1 min 14 secs
Principle of the LAL Test
1 min 05 secs
The FDA’s recommended LAL method
1 min 06 secs
Comparison of methods
1 min 15 secs
Microbial examination of sterile products – sterility test
1 min 12 secs
Types of media
1 min 18 secs
Sampling
1 min 07 secs
Sterility testing methods
1 min 10 secs
Direct inoculation
1 min 21 secs
Interpretation of results
1 min 18 secs
Sterility Failures: What happens next?
1 min 15 secs
Laboratory system investigations
1 min 01 secs
Manufacturing system investigations
1 min 04 secs
Concluding sterility test failure investigations
1 min 08 secs
Antimicrobial effectiveness test
1 min 19 secs
Product categories
1 min 22 secs
Test organisms
1 min 02 secs
Media
1 min 11 secs
Procedure
1 min 17 secs
Criteria for antimicrobial effectiveness
1 min 05 secs
What is method validation?
1 min 22 secs
Principle
52 secs
Types of microbiological methods
1 min 12 secs
Validation parameters
1 min 30 secs
Validation parameters per test
1 min 42 secs
What monitoring can do?
1 min 22 secs
Methods of monitoring
1 min 17 secs
Active air sampling
1 min 29 secs
Active air sampling - method
1 min 31 secs
Passive air sampling (Settle plates)
1 min 39 secs
Passive air sampling (Settle plates) – method
1 min 50 secs
Contact plates
1 min 55 secs
Contact plate – method
47 secs
Swabs
1 min 50 secs
Swabs – method
52 secs
Monitoring frequencies
1 min 29 secs
Limits for microbiological monitoring
1 min 40 secs
Some tips for microbiological monitoring
1 min 33 secs
Conclusion
Final Assessment
Certification
