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Course offering number:0711-722
Course ID:
2185
Conducting Compliant Endotoxin Testing
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course will benefit professionals in the areas of pharmaceuticals, biotechnology, medical devices industries, sterile pharmaceutical compounding and cellular and tissue therapy. This training is applicable to:-
Microbiologists
- Chemists and Managers
- Supervisors
- Quality Assurance
- Technicians concerned with endotoxin testing in Quality Control departments
- Regulatory Affairs
- Research and Development
The course will benefit both the experienced manager and the novice technician who wishes to understand the overall regulatory context of the test.
Description
The essential elements of the bacterial endotoxins test are addressed in this 11/2 hour course. Proper and appropriate inclusion of these elements in an LAL testing program will result in compliant testing. Performance of properly understood endotoxins tests benefits any company releasing products with endotoxin specifications and may avoid significant compliance problems.
Module 1:
General Principles and Introduction
The five essentials of endotoxin testing
The USP, EP and JP Harmonized Endotoxins Test Chapters
Prerequisites for endotoxins tests:
Apparatus and Glassware
Standard Endotoxin stock solution and dilutions
Preparatory Testing
Endotoxin Limits
Maximum Valid Dilution (MVD)
Module 2:
USP Bacterial Endotoxins Test Requirements
for Gel-clot and Photometric Techniques
Photometric Techniques
The Gel-clot method
Preparatory Testing
Gel-clot Limit Test
The Gel-clot Assay
Photometric Techniques
Preparatory Testing
Gel-clot Limit Test
Test Procedure
Module 3:
Compliant LAL Tests and the FDA Guideline
Technician and Laboratory Qualification
Control Standard Endotoxin (CSE)
CSE potency determination
The USP position on CSEs
Certificates of Analysis (Potency)
When to repeat validation
Pooling Samples for Testing
Out of Specification Results and Repeat Testing