The Center for Professional Advancement, Your Computer - An Online Training Format
October 30, 2007
Who Should Attend
This online training course will benefit professionals in the areas of pharmaceuticals, biotechnology, medical devices industries, sterile pharmaceutical compounding and cellular and tissue therapy. This training is applicable to:
The course will benefit both the experienced manager and the novice technician who wishes to understand the overall regulatory context of the test.
- Chemists and Managers
- Quality Assurance
- Technicians concerned with endotoxin testing in Quality Control departments
- Regulatory Affairs
- Research and Development
The essential elements of the bacterial endotoxins test are addressed in this 11/2 hour course. Proper and appropriate inclusion of these elements in an LAL testing program will result in compliant testing. Performance of properly understood endotoxins tests benefits any company releasing products with endotoxin specifications and may avoid significant compliance problems.
Module 1: General Principles and Introduction The five essentials of endotoxin testing The USP, EP and JP Harmonized Endotoxins Test Chapters Prerequisites for endotoxins tests: Apparatus and Glassware Standard Endotoxin stock solution and dilutions Preparatory Testing
Endotoxin Limits Maximum Valid Dilution (MVD)
Module 2: USP Bacterial Endotoxins Test Requirements for Gel-clot and Photometric Techniques Photometric Techniques The Gel-clot method Preparatory Testing Gel-clot Limit Test The Gel-clot Assay Photometric Techniques Preparatory Testing Gel-clot Limit Test Test Procedure
Module 3: Compliant LAL Tests and the FDA Guideline Technician and Laboratory Qualification Control Standard Endotoxin (CSE) CSE potency determination The USP position on CSEs Certificates of Analysis (Potency) When to repeat validation Pooling Samples for Testing Out of Specification Results and Repeat Testing
Dr. Michael E. Dawson; Director of Regulatory Affairs for Associates of Cape Cod, Inc. (ACC)
Dr. Michael E. Dawson is Director of Regulatory Affairs at Associates of Cape Cod, Inc. (ACC). His responsibilities include regulatory submissions world-wide and compliance issues for ACC. Previously he been responsible for manufacturing responsibilities and directed development of instrumentation and of software, with supporting validation information. Dr. Dawson speaks frequently on endotoxin related issues and has directed many courses on endotoxin testing and the regulatory aspects of its application in the health care industries. He and is the author of many publications and has served on expert panels. He is also editor of the company newsletter, the LAL Update.
Dr. Dawson received his Bachelors degree from the University of Wales and his doctorate from the University of Southampton, both in the United Kingdom. He is a member of the American Association for the Advancement of Science, the Parenteral Drug Association, the International Endotoxin Society, the Association for the Advancement of Medical Instrumentation and the Regulatory Affairs Professional Society.