Flora Noitsis – 29 Sep 2022

Flora Noitsis holds a Hons. BSc. in Microbiology and Biochemistry from the University of Toronto.  She started her pharmaceutical career working with private pharmaceutical laboratory as a bench microbiologist and […]

Flora Noitsis – 29 Sep 2022

by Kim

Flora Noitsis holds a Hons. BSc. in Microbiology and Biochemistry from the University of Toronto.  She started her pharmaceutical career working with private pharmaceutical laboratory as a bench microbiologist and Quality Control person for several drug importing companies and represented them during Health Canada inspections.

Flora started with Health Canada in 1991 with the Drug Compliance and Verification Unit and moved to the drug GMP inspection unit where for 17 years she inspected large companies manufacturing injectable, oral, topical, drugs for human and veterinary use for GMP compliance.   In 2008 Flora moved to the Clinical Trial Compliance Program where she planned and conducted inspections and compliance verifications of sponsors, investigators and CRO establishments.  She represented Health Canada on a PIC/s GCP joint inspection group which included inspectors from MHRA and the EU. Most recently, as part of Health Canada’s pilot project to modernize the Clinical Trial Compliance Program, Flora was assigned to conducting clinical trial inspections of bioequivalence studies which included both GCP and analytical results assessment.

In May 2022 Flora joined BioAcuity Consulting Inc. which specializes in providing quality, compliance. regulatory affairs, and operations consulting services to GMP, GCP, GLP, and GPP regulated bio/pharmaceutical, medical device, natural health, and other related life sciences organizations and companies.

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