About me
Anna (M. Sc. Pharm.) is a Quality Assurance professional responsible for auditing, procedures development and supports of ongoing clinical operations in an inspection ready mindset. She started her journey in clinical trials in 2006 as clinical monitor and moved to QA area in 2009 (internal auditor at small CRO). Over the years Anna audited multiple clinical vendors, clinical sites and TMFs in multiple EU countries, in US, Canada, Russia against ICH E6, ISO 9001, ISO 14385, local regulations, standards, guidelines, clinical protocols and contracts. She wrote multiple cross-department procedures and multiple audit plans (internal and external). Anna is experienced in preparation, hosting and follow up of EMA and FDA inspections at CRO, Pharma companies and clinical sites. Anna passed ASQ exam for Certified Quality Auditor in 2019. Anna was responsible for de novo implementation of eTMF in two companies, prep and audit for ISO9001 and ISO13485 certification, CAPA management, process improvements initiatives. All of her auditing skills (as well as project management skills) come handy during clinical site selection for the audit.
Anna currently lives in Bay Area, CA, USA with her family where she enjoys reading science fiction books, playing basketball with her kids, creating stained glass in her garage and chauffeuring her kids around.