What we’ll cover
✓ Choosing sampling sites and timing that fit PET operations
✓ Setting meaningful alert and action levels
✓ Trending results when sample numbers are small
✓ Responding to excursions
✓ Using risk assessment to document the reasoning behind each
COALITION WEBINAR
Putting Environmental Monitoring into Practice in PET Manufacturing
Translating environmental monitoring requirements into a practical program can be challenging, especially for PET operations. This session focuses on applying those requirements day to day.
Join microbiology and contamination control expert Kim Sobien for a practical look at how to choose sampling sites and timing set meaningful alert and action levels, trend results when sample numbers are small, respond to excursions, and use risk assessment to document the reasoning behind each decision.
SPEAKER
Kim Sobien
Kim brings 25+ years of pharmaceutical industry experience across quality, compliance, and technical roles with injectable products, including contract manufacturing, pre-filled syringe generics, PET and non-PET radiopharmaceuticals, and biologics. Her expertise spans microbiology, sterility assurance, contamination control, investigations, radiopharmaceutical process design, environmental monitoring, and inspection readiness.
Kim holds a BS in Microbiology from the University of Wisconsin–La Crosse and an MBA with an emphasis in Global Management from the University of Phoenix. She is President-Elect of the PDA Southeast Chapter, Co-Lead for the PDA EM/Microbiology Interest Group, and a past co-chair of the PDA Pharmaceutical Microbiology Conference.
Register
Please use the form below to register, or if you prefer you can click here to open a new window. Coalition members register at no cost, non-members register for $50. Webinar access details and the meeting link will be emailed to registrants closer to the event.