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President, COMPLIANCE AND QUALITY INTEGRATION (CQI) CONSULTING
Arti Bajpai is a strategic leader with over 30 years of experience in the pharmaceutical industry. Ms. Bajpai’s diverse experience provides the foundation from which she leads innovative change to establish proactive compliance and quality management leading to a culture of compliance within organizations.
Currently CQI consulting provides strategic management consulting services to pharmaceutical, CROs and clinical investigator sites on Process development, building Quality Management Systems, Risk Assessments and Gap Analysis, Clinical Research Site Quality Improvement, GCP QA Audits, Regulatory Inspection Readiness and Compliance Program Design and Implementation.
Arti is also leading a global initiative for ACRES to develop global Clinical Research Investigator Site Accreditation Standards. These standards will be developed using global alliances and will lead to accreditation of clinical research sites.
Before launching CQI Consulting in 2013, Ms. Bajpai held positions at Adria Labs, Pfizer and Shire in disciplines of Quality Assurance, Compliance, Clinical Operations, and Medical Affairs. Ms. Bajpai led teams who helped establish a compliant infrastructure for robust clinical research programs in non-ICH countries and regions such as India, Africa, and Latin America. Most recently as the head of Compliance and Quality Improvement Ms. Bajpai provided strategic and tactical support for R&D, establishing quality metrics and processes which enabled the organization to achieve quality and compliance objectives.
Ms. Bajpai is a visionary team builder and motivator who thrives on continuous improvement and driving change to “make a positive difference.”
Arti has spoken at the following ExL Events: