BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T155957Z UID:9860552f-bd73-4115-a2a6-ca6193d63473 DTSTART:20210323T130000 DTEND:20210324T130000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nIt is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation need s differ based on the filtration requirement. This webinar will offer atte ndees a comprehensive understanding of the same while emphasizing the diff erent types of sterilizing filtration available and their application to y our particular system. For instance\, the application of sterile filtratio n to use-point compressed air will be discussed in detail.
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\n\nWhy Should You Attend
\n\nThis course will offer a broad review of:
\n\nThe proper validat ion of sterile filtration is important to ensure that the filter will repr oducibly remove undesirable components (bioburden) while allowing passage of desirable components (drug product). The operating parameters of time\, pressure and temperature will be fully discussed along with the filter 9\;s potential effect on the product (compatibility\, leachables\, fibers\ , endotoxin\, etc.). Microbial retention challenge testing is one of the v alidation requirements and the instructor will offer insights on the same.
\n\nAt the end of the course\, the instructor will present a compil ation of all FDA/EU GMP regulatory guidances concerning sterile filtration . In keeping with these guidances and requirements\, the responsibilities of the filter manufacturer vs. the filter user will be thoroughly analyzed .
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\n\nSession Highlights< /p>\n\n
Sterile Filtration - Importance of Quality
\n < /li>\nSterility Assurance of Sterile Filtration
\nSterile Filtration System Design
\n \nDiscussi on of Different Filtration Media Properties and Retention Mechanisms
\nMethods for Sterilization of Filters
\nValidation of Sterile Filter Systems
\nMicrobi al Retention Challenge Testing
\nIntegrity Testing p>\n
Product Compatibility Testing
\nExtractable/Leachable Testing
\nRegulatory Requir ements
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\nWho Wi ll Benefit
\n\nThis webinar will provide valuable assistanc e to all personnel in:
\n\nQuality Assurance
\n \nEnvironmental Monitoring
\nMicrobiolo gy
\nManufacturing
\nValidatio n
\nEngineering
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