Diane serves as a session chair for the “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and “Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product” programs.  She is chair of the PCRI/PODP Leachables and Extractables Working Group and will discuss the goals and objectives of the group at a session on Tuesday, December 10.

Additional topics include:

USP General Chapter <661> Plastic Packaging Systems and Their Materials of Construction
< 661.1> Plastic Materials of Construction
< 661.2> Plastic Packaging Systems for Pharmaceutical Use
< 1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
< 1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
< 1664.1> Orally Inhaled and Nasal Drug Products
PQRI safety thresholds and best practices for extractables and leachables in parenterals and ophthalmic drug products