Sallie McLaughlin

Sallie McLaughlin joined the QA Consulting team in 2004. She serves as QA Consulting’s resident expert in microbiology and sterilization, with over 30 years of diverse experience in the medical device industry.  Sallie’s sterilization experience encompasses virtually all industry-recognized practices and her in-depth knowledge of FDA and regulatory practices make her a valuable member of the QA Consulting team. Her specialties include validating sterilization processes, biocompatibility testing, cleanroom validation, and environmental monitoring programs.

Sallie’s experience includes 13 years at the Food and Drug Administration (FDA) in Minneapolis, MN.  In this role, she was responsible for microbiological analyses, team investigations, and method development/validation.   Sallie also worked at Pfizer Hospital Products Group Schneider USA in Minneapolis, MN where she implemented a microbiological services department, managed sterility assurance activities, and a biocompatibility testing program for new products.  Most recently, Sallie worked in Austin, TX at CarboMedics where she developed in-house expertise in Microbiology, directed all sterility assurance activities, implemented environmental monitoring programs, and was responsible for sterility assurance for a sister company.

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