FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

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

Instructor Profile:

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining quality management systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Ms. Dunston has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, she has worked with US FDA agents to ensure compliance for her clients.

Her international experience has assisted global organizations such as Johnson and Johnson, The Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

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