This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another - understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
Why Should You Attend:
This guidance does not cover the entire subject of pyrogen and endotoxins testing. Instead, it addresses those issues that may be subject to misinterpretation and are not covered in compendial procedures or in currently available documents. There should already be a thorough understanding of these compendial references. The recommendations should be incorporated by organization in order to adopt the current thinking of the agency to prevent observations.Learning Objectives:
- Provide a review of the current testing requirements
- Understanding what happened to the old 87/91 LAL Guidance for Industry
- Learn what has replaced it and why
- Learn of common issue misunderstandings and misinterpretations
- Determine who comprised the Agency Guidance team involved with in this new proposed guidance
- Learn of the documents supporting this new guidance
- Learn about sampling, storage, and handling
- How does one transition from one bacterial endotoxin test to another - understand the RPT (Rabbit Pyrogen Test)
- Learn about the Monocyte Activation Test (MAT)
- Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
- Understand the FDA’s expectation for screening of therapeutic products
Areas Covered in the Webinar:
- Examine the 1987 Guidance for Industry Document
- Review Current Testing Requirements
- Overview of New Guidance for Industry LAL
- Examine the Bases for Bacterial Endotoxin Tests
- Learn of the Documents Supporting the Proposed, New FDA Guidance
- Learn Which Specific Chapter is Yet to be Harmonized
- Learn of the Typical Issues Confronting the End User of LAL Testing
- Warning Letter Examples
Who Will Benefit:
- Pharmaceutical manufacturers dealing with solid dosage, vaccines and biologics
- Personnel in contract laboratories
- API manufacturers
- Medical device manufacturers
Course Provider
Angela Dunston,
