Bacterial Endotoxin Testing (LAL), Product Validation and Suitability Tests

This webinar will help the attendee gain an understanding of 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), the different testing methodologies and the criticality of the BET test result to the release of cGMP manufactured products.

Who will benefit:

This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries that manufactures cGMP product requiring bacterial endotoxin release assay. The employees who will benefit most include:

• Quality Control
• Quality Analyst
• Testing and Validation
• Manufacturing
• Engineering
• Quality Assurance

Instructor Profile:

Charity Ogunsanya, has more than 23 years of extensive experience within several industries as they apply to Aseptic Processing, Contamination Control, Quality Control, Microbiology, Sterility Assurance, Stability, Quality Assurance, Vaccine Development, Product Design, Testing and Validation. She is also vastly experienced in both national and international regulatory bodies’ requirements such as the FDA, EMEA, EU, TGA, JP, ISO etc. Throughout her career, she has worked individually and within teams to successfully pass various national and international regulatory bodies audits, pre-approval and post approval inspections amongst others.