How to Use and Interpret Data for Particle Counters and Microbial Air Samplers - New Course

Bethesda, MD
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

This course will enable participants to use and interpret data for particle counters and microbial air samplers in cleanrooms. Topics will include the impact of total particulates and microbial contamination in ISO 5 environments. Participants will also be able to set alert and action levels for total particle and microbial contamination based on collected data, prepare a trend analysis and annual report, and manage out of specifications.

Who Should Attend

Managers in pharmaceutical production, quality assurance, microbiological laboratory, and maintenance and engineering will benefit from taking this course.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:
  • Create data trends and data interpretation for total particulates in cleanroom air
  • Create data trends and data interpretation for total microbial contamination in cleanroom air
  • Manage Out of Specifications (OOS)
  • Set alert and action levels for total particulate and microbial levels in cleanroom air
Agenda is subject to change.

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Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Road
Bethesda, MD , United States

Gilberto Dalmaso, PhD, Global Aseptic Processes Development Manager, Particle Measuring Systems

Dr. Gilberto Dalmaso has over 25 years experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM) that improve quality and process understanding while yielding significant cost savings. In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Aseptic Processes Development Manager for Particle Measuring Systems. In this role, 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. With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, technologies and methods.