Americas

Date: December 6
Time: 10:00 AM EST (UTC -5)

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Europe, Middle East, Africa

Date: December 6
Time: 10:00 AM CET (UTC +1)

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Asia Pacific

Date: December 6
Time: 4:00 PM UTC +8

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The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbial Control and Monitoring of Aseptic Processing Environments Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (CFU). 

Key Learning Objectives:

  • Main changes from the previous revision
  • Recommendations when using CRR
  • A case study
  • Conclusions on CRR

Keynote Speaker

Gilberto Dalmaso

PhD - Global Consultant andSubject Matter Experts Team Manager, Life Sciences Division, Particle Measuring Systems

Gilberto has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. Today he is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States. Dr. Dalmaso is the Global Consultant and Subject Matters Experts Team Manager for Particle Measuring Systems. In this role and with his team of subject matters experts, he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.

Date: December 12
Time: 9:00 AM UTC+7

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Chemical quality monitoring programs includes data gathered from the time chemicals are received all the way to the point of process. This may involve the use of grab samples and offline particle contamination monitoring to understand chemical quality. Establishing a well-controlled sampling protocol that does not contaminate the fluid and produce false positives is critical for successful grab sampling. Best known methods to minimize external contamination in the sample are presented to support data optimization. Customers are encouraged to incorporate these concepts in their own process development. 

What You Will Learn

  • Methods to reduce variation when taking samples for offline analysis

Who Should Attend

  • Anyone involved in taking samples for offline analysis
  • Anyone analyzing particle data from offline measurements

Presenter

Dwight Beal

Senior Global Applications Engineer

With over 35 years experience in optical particle counters, Mr. Beal has turned his focus toward helping customers overcome their most difficult particle monitoring challenges and finding ways to meet their requirements in the most cost effective way possible. He finds liquid applications provide the greatest challenges that are often quite simple to overcome.