Verification of Containment Performance
With APIs becoming more and more potent, the importance of proper functioning containment equipment is more significant now than ever before. This workshop will discuss the proper design for a study to evaluate the performance of these devices. It will examine differences between factory and site acceptance testing, the selection of a surrogate dust to use during the study, proper selection of air and surface sampling sites, and how to evaluate the results to determine whether the containment device meets the design specifications. The attendee will leave the course with a better understanding of the importance of each of the above-mentioned aspects of the containment verification process.
Bob Sussman, Managing Director, SafeBridge Consultants
Managing Variability in OEL & How to Calculate OEL
You have one API and two different OELs from experts. Why is that? What should you do? Do you really need an expert OEL?
The goal of this workshop is to help you discover the answers to these and other OEL questions such as:
What do I do when one toxicologist says my API is potent, and the other says it isn’t? What does “potent” really mean? What’s contained in that black box toxicologists use to determine OELs? Can I derive one myself? What OELs should I use for molecules that have no toxicological data?
With easy-to-understand language (assuming you know basic organic chemistry), we will collaboratively explain, demonstrate (in real-time on a computer using open-source apps), practice, and evaluate a process used to derive OELs and identify special hazards. By the end of this workshop, you will understand why OELs can vary, you will have your own OEL examples, and you will have a decision matrix so you can decide if you really need an expert at all.
Mark Maier, Managing Partner, BioRisk Sciences