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.
“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