cGMP drug products rely on the bacterial Endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
This course is designed to provide the experienced technician with a more detailed understanding of how an LAL testing program can be applied to quality control.
Why You Should Attend:
This 60-minute training will discuss the requirements of current USP <85> Bacterial Endotoxin Test (BET) and European Pharmacopoeia (Chapter 2.6.14). It will address the different LAL testing methodologies and how to choose the best test method applicable to the product type. This webinar will outline the importance, regulatory and testing requirements of products for compliance by applying the sequential steps in testing the product to rule out the presence of Endotoxins.
This webinar will provide a great resource to companies in the Pharmaceutical, Biotechnology and Medical Device Industries that manufacture cGMP products requiring bacterial Endotoxin release assay.
- Introduction to current USP <85> Bacterial Endotoxin Test
- Types of Bacterial Endotoxin Test Methodologies
- Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
- Initiating a Bacterial Endotoxin Test-Initial Considerations
- LAL Testing Materials and Reagent Qualification
- Products Receipt, Handling and Storage
- Product Processing
- Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
- Relationship of Endotoxin Test (LAL) with other Production and Process Controls
- Quality Assurance Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Quality Control Departments
- Manufacturing Departments
- Engineering Departments
- Compliance Departments
- Quality Auditors
- Microbiology Specialists