Paula Haigazian

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.

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A Step-by-Step Guide to ISO 9001:2015 Transition

ISO 9001:2015
Management Training

“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013