Recording from Wednesday, March 25, 2020

The joint PDA IPEC risk assessment for excipient technical report has recently been published. The report provides guidance to drug manufacturers on how to tackle the risk assessments for excipients used in finished drugs and provides several examples that can be used by manufacturers in their quality programs. The document also provides a mechanism to review existing programs and fine-tune the risk assessment process to align with industry best practices.

Learning Objectives
Attendees were able to:
> Understand the risk assessment framework
> Walk away with examples to apply in their company’s internal risk assessment program
> Develop a strategy to review existing programs and identify areas for continuous improvement
> Fine-tune their risk assessment process to meet the ever-increasing expectations of regulators for risk assessments