In-house Courses
The Bacterial Endotoxin Test:
Current Technology, Regulations, and Audit Strategy
OUTLINE
This comprehensive course is designed to educate participants in the theory and practical applications of the bacterial endotoxin test. It is taught by an independent expert, not affiliated with any endotoxin vendor and will examine the strengths and weaknesses of every commercial vendor and technology.
This course is intended for QA, QC and Regulatory professionals who want to expand their knowledge of the bacterial endotoxins test, and discover its usefulness as a diagnostic and control tool for the parenteral industry. Lab managers and technicians will learn more about the theory and application of the LAL test. Participants will gain a full and objective understanding of the test through solving mathematical problems, analyzing case studies, discussing of FDA citations, and applying compendial requirements, GMP regulations and FDA’s “Risk-Based Approach” to product quality. A culminating activity will be to plan an audit of a contract manufacturing and testing facility from a BET perspective.
Who Should Attend
This course is intended for laboratory managers and/or technicians who would like to learn more about the theory and practical application of the Bacterial Endotoxin Test. No previous experience is require this course will be useful if you are newly assigned to oversee an LAL function, or are an experienced technician who would like to learn more about the current technology.
Learning Objectives
At the completion of this course, attendees will be able to:
- The methodology of the Bacterial Endotoxins Test, both gel clot and photometric
- Benefits and limitations of the various BET assays
- Compendial, FDA and cGMP requirements
- The pragmatic use of BET as a tool for qualification, validation
- The use of BET as a tool for process control using a risk-based approach
- What to look for in an audit of a contract manufacturing and testing facility
Please Note:
It is our intent to make our course a helpful to you as possible. It is offered through the Microbiology Network, and taught by recognized experts in the field. If you have a topic of special interest, or any questions of particular importance to you, please let us know in advance. This will allow the instructors an opportunity to incorporate your concerns into the course. We know how critical your time and money are, and will do everything possible to ensure ensure that you get value from this experience.
Note: This course is being offered in cooperation with the Microbiology Network
Bring this course to your location
Available Course Offerings
|
