USP <665> on Single-Use System Characterization
WEBINAR
Single-use plastic systems are being utilized more frequently, especially for COVID-19 vaccine manufacturing. However, issues regarding the standardization of quality information limit implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, we discuss approaches to decision-making based on the extractables data package. In addition, we highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Expert
Simone specializes in Single-Use Technology and filtration within biopharmaceutical manufacturing. She provides regulatory guidance to diverse stakeholders and has helped many drug manufacturers successfully implement Single-Use Technology. Her main focus is to ensure product performance meets quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and BioPhorum. She holds a Ph.D. in Microbiology from the University of Frankfurt.
Pharma and biopharma manufacturing
- mRNA
期间:1h
语言:English
场次 1:往期 July 15, 2021