Webinar Download: A Safety Assessment of Extractables and Leachables

Toxicological risk assessments address the risks associated with exposures to chemical substances that can potentially leach from pharmaceutical packaging, or process equipment. How do you evaluate whether the presence of these leachable compounds at the analyzed levels may be of concern? Which regulatory guidelines and worst-case scenarios should be considered? How do you extrapolate from this evaluation to gain an understanding of the predicted patterns and levels of exposure for the various substances and properly document results so that product development may continue at the manufacturer’s discretion?

In a forthcoming webinar Lois Haighton, Director, Intertek Scientific and Regulatory Consultancy provides information on the risk assessment component of an extractables/leachables evaluation with case studies.

Please fill out the form below to view the webinar recording.