GCP Auditor School: 10-week international online training in GCP auditing

Maxim is an independent international GCP auditor and trainer with over 15 years of experience in the pharmaceutical and clinical industry across Europe, Africa, and CIS regions. A certified MRQA and SQA expert, he combines a medical background with quality management experience. He specializes in GCP audits, FDA & EMA inspection preparation (including mock inspections), and develops Quality Management Systems (QMS) for sponsors and CROs. His practical, audit-based approach forms the foundation of THE QARP's training programmes.

Stanislav Praslov, MD, RQAP-GCP, is a lead auditor and trainer with over 20 years of international clinical research experience. A certified RQAP-GCP and MRQA member, he brings authoritative expertise in ICH-GCP and global regulations. His practice includes conducting more than 90 GCP audits, from investigator sites and CROs to mock regulatory inspections across 15+ countries. This direct, hands-on experience auditing all parts of the trial ecosystem provides students with real-world insights. Having worked in sponsor, CRO, and independent consultant roles, he teaches practical strategies from multiple perspectives. His training equips auditors with the skills to ensure quality and navigate complex compliance challenges worldwide.

Satyam has 28 years of global quality assurance experience in GXPs across the pharmaceutical and CRO industry. Coming from a family with many teachers, is passionate to share his learning from the 435+ audits he has conducted in 23 countries. An enthusiastic interviewer during audits who loves to understand auditee processes and perspectives, he has learnt a lot from the auditees and is passionate to share it with anyone interested in listening to an auditor! Having delivered many structured and not-so-structured training on a variety of topics during his long career, he aims to deliver interactive sessions with real-life examples and case studies whenever he gets opportunities. His experience of conducting a variety of internal and external audits and for many different clients will certainly benefit the attendees of the Auditor School.

Heather Armstrong is a clinical research and quality assurance leader with over 20 years of global experience across all phases of clinical development. Specializing in GCP and GLP Quality Assurance, she brings deep expertise in data integrity, computer system validation, vendor and site auditing, and inspection readiness for agencies including FDA, EMA, PMDA, and MHRA. Heather has conducted audits across North America, Europe, and Asia and has supported programs in more than 20 therapeutic areas, including oncology, endocrinology, neurology, biosimilars, and infectious disease. She is known for her practical, strategic approach to quality and her ability to translate complex regulatory requirements into clear, actionable guidance.

A seasoned Quality Assurance professional with over 25 years of global experience in clinical research, bringing deep expertise in quality assurance audits, QMS management, SOP development, inspection readiness and training. Driven by the belief that quality should empower—not hinder—clinical trials, passionate about transforming audits into value-adding experiences that protect data integrity and, ultimately, patient safety.

As a Principal Consultant, leading the development, execution, and continuous improvement of Quality Management Systems to ensure robust compliance with GCP, GLP, and GCLP across pharmaceutical and CRO environments. Providing end-to-end QMS and QA services to clients, including GXP QA audits, inspection preparation and hosting, and strategic gap assessments of processes and systems. Supporting sponsors and vendors with risk-based audit planning, CAPA and root cause analysis, and regulatory inspection readiness, leveraging experience from over 350 GxP audits and multiple global inspection readiness programs.

Suheila Abdul-Karrim is an independent clinical research consultant, auditor and trainer with over 30 years of clinical research experience. Based in South Africa, she has maintained certifications in Auditing (RQAP-GCP), Monitoring (CCRA) and Medical Devices (ACRP-MDP). She conducts audits across Africa, Europe, Asia and the Americas. She trains investigators and CRAs on ICH-GCP both locally and internationally. She is actively involved in professional organizations. She is on the Academy Board of Trustees for The Association of Clinical Research Professionals and is chairperson for the Quality Assurance Consultants committee for the Society of Quality Assurance. Suheila has made significant contributions to the field of clinical research and is committed to advancing medical knowledge and ensuring the highest standards of research.

Retha is a highly qualified clinical research consultant and auditor with a deep academic foundation in ethics, holding two Master's degrees in Medical Law & Ethics and Applied Ethics. As the first author of publications and a book on Informed Consent, she brings focused expertise on the webinar's core topic. As the first author of publications and a book on Informed Consent, she brings focused expertise on the webinar's core topic. Her career spans senior international clinical operations and quality assurance management across Africa, the Middle East, and Europe, complemented by extensive experience developing and facilitating accredited training. She has been conducting compliance audits of international clinical trials since 2008.