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GCP Auditor

QA Director

  • She comes with an extensive experience in Quality assurance with her core competence in planning and delegating audits.

  • She has handled inspections and conducted more than 20 site audits and 8 vendor audits

  • She has conducted audit for a global Phase III program for gastroenterology tertiary care super specialty hospital in Delhi.

  • She has as a part of Sponsor QA program of large phase III Oncology Study on DLBCL has performed Site Audits at 6 high recruiting sites, suggested CAPA, supported team in implementing CA and ensured escalation of critical compliance issues.

  • Our Auditor also has an experience in facing FDA Inspection at a Site in Delhi for a global Phase III study.

  • She performed Mock Inspection programme for private multispecialty hospitals as part of their FDA Inspection preparation programme.

  • As part of training and development our Auditor has also conducted Corporate GCP training programmes for investigators, Ethics committees and site teams.

  • Trained and prepared several Institutional Ethics Committees for regulatory inspections.

  • She was also GCP consultant for a Dedicated Dermatology CRO

  • She has experience in monitoring Phase I study of Colon and Colorectal Cancer in Stage III b patients which involved overseeing of housing, dosing, and blood sampling of patients in the hospital set up.

  • Her experience in clinical research also includes Project Management of a global, therapeutic equivalence study on anti-acne product running in 10 sites in India and evaluation of 3 BA/BE CROs with Client for phase I trials in Diabetes and Acne Studies.

  • She was also a corporate trainer and imparted training in Clinical Operations, Monitoring (Basic and Advanced Level) Quality Assurance and Quality Control in clinical trials, SOPs, Audits, Inspections, Clinical trial management to CRAs, Senior CRAs, Project Managers, HODs etc.

  • GCP Auditor

  • Our Auditor comes with comprehensive experience of 20 years specializing in Clinical trials (Phase-I to IV), Bioavailability & Bioequivalence Studies, Documentation Procedures and Quality Systems.

  • Has audited all the major CROs in India for their systems and processes for efficiency and compliance.

  • Has provided Regulatory Support through alliance partners for getting BE-NOC, T-License etc. from the State Regulatory bodies.

  • Has hosted inspections of various regulatory agencies (US-FDA, affsaps, ANVISA, AGES-Austria) of the facility and the scientific data leading to no major observations or findings.

  • Has implemented quality systems as per USFDA cGLP, cGMP guidelines and have conducted quality system audits for a multinational clinical research giant

  • Formerly Head for clinical research operations and has led and mentored a team of over 60 individuals across diverse verticals- Bioanalytical, PK & Statistical, Clinical Operations, Medical Writing, and Regulatory affairs.

  • Was also the Head of Bioanalytical and Pharmacokinetic Operations where in which his key responsibilities included as that of a Study Director for all the assigned clinical trials done In-house, giving PK inputs for all the study protocols, and reviewing PK and statistical analysis for its authenticity and accuracy.

  • Prior to his work as the Head of operations she was appointed as Senior Research Scientist for Clinical Pharmacology and Pharmacokinetics where in which she conducted around 100 pilot and pivotal bio-availability and bio-equivalence studies for various immediate release, delayed release and extended release formulations as per approved protocols to assess their pharmacokinetic behaviour.

  • Has authored many international publications on drug development.

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in