Associate Director, QUID, Buenos Aires, CABA, Argentina
Paula Haigazian is ISO 9001, 15189 consultant as well as GCP and GLP auditor at QUID-Quality In Drugs and Devices Latin American Consulting- Her experience is based on GCP audits: Sites, CROs and vendors (Labs, Depots), SOPs development and review for sponsors (Pharmaceuticals /biotech companies/ CROs, AROs), clinical sites and labs. More than 60 procedures manual developed/reviewed.
She is also, GLP Responsible, in charge of review of SOPs, training and inspection/audits activities. Among her responsibilities are Regulatory advisory and Vendor selection, pharmaceuticals, clinical labs, animal care facilities. Since 2007-, she has been SAFyBI-Member/Argentinean Society of Industrial Pharmacists and Biochemists and since 2008, member of SQA-Member, the Society of Quality Assurance.
Together with IRAM and as part of FECICLA- Ethics and Quality in Clinical Research in LATAM Foundation-she has organized the first conference on ISO 9001 in Clinical Research as well as being the responsible of the process of certifying the first clinical site in her country.