Netta Fulga Email & Phone Number

Toronto, Canada Area

NetValue BioConsulting Inc. is a boutique healthcare industry consulting firm, specializing in product and clinical development, regulatory affairs and quality assurance

Toronto, Canada Area

Responsible for the establishment of a Quality Management System from inception in the clinical laboratory, and led to a successful achievement of accreditation. Managed and maintained the Quality Management System, while leading and educating staff to engage and improve processes.● Established a Quality Management System from inception within 2.5 years, in compliance with international standards and GLP, leading to a successful achievement of Ontario Laboratory Accreditation, based… Show more Responsible for the establishment of a Quality Management System from inception in the clinical laboratory, and led to a successful achievement of accreditation. Managed and maintained the Quality Management System, while leading and educating staff to engage and improve processes.● Established a Quality Management System from inception within 2.5 years, in compliance with international standards and GLP, leading to a successful achievement of Ontario Laboratory Accreditation, based on ISO 15189● Maintained the Quality Management System: Performed comprehensive internal audits; implemented a Corrective and Preventing Action (CAPA) system; performed Management Review of the System; conducted reviews of external and internal Quality Control (QC) programs; kept document database current; trained and educated lab staff on the Quality Management System● Managed lab operations, supervised staff and conducted competency assessments, planned and managed the project of relocating the laboratory to a new facility with minimal downtime● Developed, reviewed and assessed the laboratory Safety Program, leading to successful safety audits● Designed and executed analytical methods and validation protocols, for the analysis of substances by LC-MS/MS and GC/MS● Developed equipment database and established routine PM, calibration and validation program Show less

Israel

Managed the Development Laboratory operations within the bio-pharmaceutical company, supervised lab researchers and led a variety of research projects.● Developed bio-generic drugs, recombinant vaccines and drug formulations● Prepared and wrote Chemistry, Manufacturing and Control (CMC) of drugs, for submission to the FDA● Wrote development reports and SOPs, submitted to company management● Designed validation protocols and reports, according to… Show more Managed the Development Laboratory operations within the bio-pharmaceutical company, supervised lab researchers and led a variety of research projects.● Developed bio-generic drugs, recombinant vaccines and drug formulations● Prepared and wrote Chemistry, Manufacturing and Control (CMC) of drugs, for submission to the FDA● Wrote development reports and SOPs, submitted to company management● Designed validation protocols and reports, according to international regulatory guidelines; FDA/CBER, ICH guidelines, USP standards Show less

Israel

Responsible for planning and performing lab research activities.● Cloned and generated an innovative active recombinant Rat Pancreatic Carboxypeptidase B in E. Coli, for my Master’s thesis, yielding to a granted patent ● Cultured bacterial and mammalian cells, isolated and analyzed plasmid and genomic DNA for cloning of recombinant proteins ● Expressed, purified and activated recombinant proteins for the development of drugs for humans