developed by The QARP Academy and ESAME Pharmaceutical Business School
GCP Auditor School
Clinical Research Auditing Certification Program
This is a specialization program in Good Clinical Practices (GCP) designed for professionals who aim to:
1. Gain the advanced, practice-oriented training required to perform effectively as a GCP auditor.
2. Upon completion of the course, take the Certification Exam and earn the official title: “Professional Specialization in GCP Auditing”.
2. Upon completion of the course, take the Certification Exam and earn the official title: “Professional Specialization in GCP Auditing”.
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Global Recognition
An internationally recognized certification jointly developed by The QARP Academy, ensuring graduates are acknowledged as leading experts in GCP auditing.
- For the first time, the program is built around practical auditor training, including:
- Real-life simulations
- Digital tools
- Interactive remote learning
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Career Advancement
Equips auditors with skills that meet global regulatory standards, positioning them for high-impact roles in clinical research and laboratory oversight worldwide.
Who is the Course for?
- For monitors, quality specialists, project managers, data managers, clinical leads, clinical trial managers, and GxP staff with at least 1 year of experience.
- Other candidates may be admitted based on an interview if they wish to specialize as AUDITORS in GCP or need to develop their knowledge.
How It Works:
- Start Date: 7th of April, 2026
End Date: June, 2026 - Duration: 10 weeks
Weekly Hours: 12 hours (3 hours per session) - Weekly Schedule:
- Days: Monday, Tuesday, Wednesday, Thursday
- Time: 18:00–21:00 CET
- Location: Online
Language: English
Price: €3,000 (three thousand euros)
*Payment in installments is available.
What does the Auditor School provide?
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You enter a high-demand professional fieldGCP auditors and quality specialists are key experts ensuring that clinical research complies with international standards and regulatory requirements. They participate in international audits and oversee high-risk projects. These professionals are in demand in pharmaceutical companies, CROs, and research laboratories.
At the same time, the number of qualified specialists in this area is limited, while the demand remains consistently high. -
You receive documentation confirming your international-level qualificationAfter completing the course, participants take the European Certification Exam, and upon passing, receive the title:
“Certified Auditor in Good Clinical Practices”.
This credential is recognized in Europe and other international regions, supporting your qualification for roles in quality oversight, auditing, and compliance across global clinical research. -
New career paths open up - both within your company and beyondAfter the course, you may transition to a quality department, start participating in internal or external audits, or join GxP compliance system development projects.
This direction scales well: from specialist to leadership roles, from national assignments to international projects. -
You increase the market value of your experienceThe program focuses on practical skills and real-life scenarios. It enables you not only to study documentation, but to understand how to act in specific professional contexts.
With this background, your profile stands out - both inside your current company and on the broader market.
Modules:
Most popular questions
Registration is considered complete only when both of the following conditions are met:
Submitting the form on our website does not count as registration and does not guarantee a place in the group.
- The participant completes an admission interview with The QARP to confirm their suitability for the course.
- The participant finalizes enrollment and payment on the ESAME website, as managed by ESAME.
Submitting the form on our website does not count as registration and does not guarantee a place in the group.
Upon successful completion, participants receive the European ESAME Certificate — “Professional Specialization in GCP and GCLP Auditing,” issued by the ESAME Pharmaceutical Business School (Spain).
The course is conducted fully online over a 10-week period. It includes live Zoom sessions, individual assignments, group discussions, practical case analysis, and a final exam. Live sessions (3 hours each) are held on weekdays in the evening.
The course follows a fixed group schedule. Attendance is important, and topic assessments are conducted during the course. While access to certain learning materials will remain available, assignments, assessments, and the final exam must be completed on time.
Each group includes 25 participants. This size allows for live interaction, small group work, and personalized feedback from instructors.
The exam consists of:
- An automated theoretical test
- A practical assignment based on an audit report excerpt
- An oral assessment on key course topics
Our team and teachers
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- Dr Maxim BunimovichMD, MRQA, SQA – Founder & Scientific Director, The QARP Academy (Barcelona, Spain)19 years in pharma, 13 years in QA. Led >900 audits and delivered >1,400 training sessions; specialises in site, TMF and CRO audits and in AI‑enhanced learning.
- Dr Stanislav PraslovMD, RQAP‑GCP, MRQA – Senior Auditor & Quality‑Systems Adviser (Mannheim, Germany)20 years’ clinical‑research experience, including 7 years of international GCP auditing and QMS development. Advises on complex GCP issues, vendor selection and CRO oversight.
- Suheila Abdul-KarrimBSc, CCRA, FACRP, RQAP‑GCP – Independent Auditor & Trainer (Johannesburg, South Africa)27 years in clinical‑trial QA, auditing and training. CCRA‑certified since 2000 and member of the ACRP Board, Content Advisory Working Group and Fellows Panel
- Heather ArmstrongBSc – Senior Quality Assurance Auditor (San Diego, USA)23 years in Clinical Trials, GCP and GLP Quality Assurance Director, Consultant supporting multi‑regional clinical trials and inspection‑readiness programmes.
- Retha BritzM.Phil (Medical Law & Ethics), MSc – Clinical Research Quality & Ethics Specialist (Johannesburg, South Africa)19 years in Audits, Consulting and Training, M.Phil in Medical Law & Ethics, Applied Ethics, M.Sc in Physiology. Author of Clinical Research Conduct in South Africa: Informed Consent and first‑author contributor to the South African Medical Journal.
- Dr Denis SyebovMD – Global GxP Quality‑Assurance Consultant (Tbilisi, Georgia)25 years in clinical research; trained in internal medicine and oncology. Conducted ~300 GxP audits worldwide and helped host/lead 115 regulatory inspections (FDA, EMA, MHRA, PMDA).
Leave a request and we will contact you!
Phone number: +34 625263964
Email: info@theqarp.com
Email: info@theqarp.com