Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

Who Should Attend
This training applies to personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries. The employees who will benefit most include:

  • Quality Control Analyst and Management 
  • Senior Management 
  • Manufacturing Associates and Management
  • Quality Assurance Analyst and Management

Those familiar with the Bacterial Endotoxin Testing (LAL), Product Validation and Suitability Tests may wish to recommend this webinar to anyone in their company that has questions about this subject.

Description
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 90-minute accredited training will discuss the requirements of current USP <85> Bacterial Endotoxin Test (BET) European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). It will address the different LAL testing methodologies and how to choose the best test method applicable to the product type. This seminar 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.