Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment

Monjit is a QA consultant with over 25 years’ experience in the development, design and conduct of GCP, GLP, cGMP and PV audits in the pharmaceutical industry. 

In 2013 Monjit founded Saffron Pharma Consulting Ltd., a QA consultancy providing Audit, Regulatory Agency Inspection support and Training services. Prior to this Monjit was employed as Global Head of R&D QA at Shire Pharmaceuticals, joining Shire in 2003 from Pfizer (formerly Pharmacia). Monjit is pharmacy graduate, holds a Post-graduate Diploma in Management and is a member of the Royal Pharmaceutical Society of Great Britain.

Dounia is currently R&D QA Director for Audit division within Servier. She has more than 25 years of experience on various positions in pharmaceutical industry (GCP, PV and GLP).

Dounia has hosted several GCP routine and pre-Approval inspections, sponsor and investigator’s sites (FDA, EMA and some local inspections) and contributed to PV inspections (MHRA, ANSM).

She conducted training on inspection readiness process to ensure the preparation and follow-up actions are executed properly.

In her previous experience, Dounia has worked on developing and optimizing processes, tools and training material on GCP inspection readiness and Sponsor / Monitor inspection management.

Jamila Joseph is a member of RQA's GCP Committee and Senior Director, QA in IQVIA based in London, UK. She has 28 years of experience in clinical research, training, regulatory strategy, risk management, and building new business lines such as Cell and Gene Therapy and Data Science. Her biotech career has spanned the development from bench to bedside of 18 market-leading biosimilars and 3 stem cell products. She is currently IQVIA’s head of Serious Breach Investigations, CAPA Centre of Excellence, and Customer QA Strategy and a fellow of the Royal Society of Medicine.