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The Center for Professional Advancement, An Online Training Format
January 29, 2008
Who Should Attend
This online training will benefit professionals in the pharmaceutical, biotechnology, medical devices industries; sterile pharmaceutical compounding; and cellular and tissue therapy.
This course is applicable to microbiologists, chemists, and managers, supervisors and technicians concerned with endotoxin testing in Quality Control departments as well as those in Quality Assurance, Regulatory Affairs, Research and Development. Description
Common causes of interference with the bacterial endotoxins test are presented in this course and specific methods to eliminate them are given. Strategies for detecting interference; validation of special treatments to overcome interference and validation of the test for endotoxins by performing the Pharmacopeial Test for Interfering Factors are all addressed. Inclusion of these elements in an LAL testing program will result in compliant testing.
This 90-minute course will benefit both the experienced manager who has been supervising endotoxin testing and the novice technician who wishes to understand and overcome interference with the test.
Module 1: Causes of Interference with the Limulus Amebocyte Lysate (LAL) Test for Endotoxin Introduction Common causes for interference and their elimination
– pH; Salts; Chelating Agents; Proteins (including blood serum and plasma); Agents that Denature Proteins; Agents that Affect Endotoxin; Lipids and Liposomes
Module 2: Overcoming Interference in Endotoxin Testing Testing for Interference Strategies to Overcome Inhibition
– Dilution; Use of Buffer; Sample Treatments including: use of other test methods, chemical modification and ultrafiltration
Module 3: Validation of Sample Treatments and the Pharmacopeial Test for Interfering Factors for Validation of the Endotoxins Test The Test for Interfering Factors
– Gel-clot Method
– Photometric Methods Conclusion
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Michael E. Dawson, Ph.D., RAC, Director of Regulatory Affairs, Associates of Cape Cod, Inc.
Dr. Dawson is Director of Regulatory Affairs at Associates of Cape Cod, Inc. (ACC). He is responsibilities for regulatory submissions world-wide and compliance issues at ACC. He has broad experience addressing interferences with the LAL test. Dr. Dawson has directed courses throughout the world on endotoxin testing and the regulatory aspects of its application in the health care industries. He and is the author of many publications and served on expert panels. He is also editor of the company newsletter, the LAL Update.
Dr. Dawson was educated in the United Kingdom, receiving his Bachelors degree from the University of Wales and his doctorate from the University of Southampton. 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. He has obtained Regulatory Affairs Certification.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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