BEGIN:VCALENDAR
PRODID:-//Microsoft Corporation//Outlook 12.0 MIMEDIR//EN
VERSION:2.0
METHOD:PUBLISH
X-MS-OLK-FORCEINSPECTOROPEN:TRUE
BEGIN:VEVENT
CLASS:PUBLIC
CREATED:20260418T085530Z
DESCRIPTION:This presentation summarizes USP General Chapter , which provides guidelines for qualifying plastic components and systems in pharmaceutical and biopharmaceutical manufacturing. It introduces a risk-based framework, starting with an initial suitability assessment and a matrix that classifies components as low, moderate, or high risk. Testing requirements—such as extraction solvents, temperature (40 °C), and duration—are tailored to each risk level to ensure science-driven practices.\nThe scope covers all drug products and biopharmaceuticals, excluding APIs for traditional small molecules and certain auxiliary items. The chapter emphasizes dynamic extraction conditions and standardized surface-area-to-solution ratios for consistency. While  is currently informational, it may become enforceable if referenced in USP notices or monographs. Alternative, scientifically justified methods are acceptable for compliance. The goal is to clarify regulatory expectations and support a flexible, risk-based approach.\n
DTSTART:20260520T133000
DTEND:20260520T140000
DTSTAMP:20260418T085530Z
LOCATION:Online
PRIORITY:5
SEQUENCE:0
SUMMARY;LANGUAGE=es-es:Tecnowebinars.com - :: USP General Chapter <665>: Separating Fact from Fiction
TRANSP:OPAQUE
UID:ad69ecbbae6a7aba5f34c6e12fb76467 Tecnowebinars.com
X-MICROSOFT-CDO-BUSYSTATUS:BUSY
X-MICROSOFT-CDO-IMPORTANCE:1
X-MICROSOFT-DISALLOW-COUNTER:FALSE
X-MS-OLK-ALLOWEXTERNCHECK:TRUE
X-MS-OLK-AUTOFILLLOCATION:FALSE
X-MS-OLK-CONFTYPE:0
BEGIN:VALARM
TRIGGER:-PT1440M
ACTION:DISPLAY
DESCRIPTION:Reminder
END:VALARM
END:VEVENT
END:VCALENDAR