Advanced GCP Auditor School: audit the complex
A 12-week specialist programme for practising GCP auditors. Each week you take on one high-risk audit domain — from TMF and CRO oversight to bioequivalence, CSV, RBQM and AI-assisted auditing — and work through it in a live audit simulation.
Foundation or Advanced?
The GCP Auditor School teaches you how to audit. The Advanced School is for auditors who already do it and want to handle the most complex audit types with confidence.
| FoundationGCP Auditor School | Advanced · Level 2Advanced Auditor School | |
|---|---|---|
| Who it's for | Clinical research professionals with 1+ year of GCP experience (CRA, QA, PM, DM) | Auditors with 1+ year of audit practice and GCP Auditor School graduates |
| Focus | Auditor role, QMS, audit standards, planning, execution, findings and CAPA, reporting | 12 specialist domains: TMF, sponsor and CRO oversight, labs, BE, PV, data management, CSV, RBQM, DCT, AI |
| Live sessions | Fridays, 3 hours | Thursdays 16:00–19:00 CET, 3-hour audit simulations |
| Dates | 05 April – 02 July 2027 | 21 January – 15 April 2027 |
| Outcome | Certified GCP Auditor (CPD UK) | Advanced certificate after the final exam |
| Fee | €2,000 (deposit + 2 instalments) | €2,500 (full or 3 instalments) |
Who is the Advanced School for?
Built for people who already lead or co-lead audits and now face high-risk sites, complex vendors and technology-driven trials.
Designed for
- GCP auditors and QA specialists with at least one year of hands-on audit experience
- Graduates of The QARP GCP Auditor School
- Lead auditors expanding into vendor, laboratory, system and PV audits
- QA managers responsible for sponsor oversight and inspection readiness
Not sure you qualify? We review every application individually and may invite you to a short admission interview.
After the programme you will be able to
- Plan and run risk-based audits of complex investigator sites, CROs and laboratories
- Assess TMF reconstructability and sponsor oversight end to end
- Audit bioequivalence studies, safety reporting, data management and statistics
- Evaluate validated state, audit trails and data integrity of clinical systems
- Audit RBQM, centralised monitoring and decentralised trials, on site or remotely
- Use AI in audits responsibly, with traceability and human accountability
12 audit domains in 12 Thursdays
Each week combines self-paced eLearning modules with a 3-hour live practice webinar, held every Thursday at 16:00 CET. Click any week to see the modules and the practice case.
0121 JanThu · 16:00 CET Advanced Investigator Site AuditsConduct risk-based audits of complex investigator sitesExpert: Satyam Kothari
eLearning modules
- Site selection and risk profiling
- Pre-audit document review
- Informed consent and eligibility
- Source data verification
- Source Data Review
- Protocol compliance
- IMP accountability
- Safety reporting
- PI oversight
- Site systems and facilities
Live practice webinar · 3 h
Complex Investigator Site Audit Simulation
- Review of a high-risk site package
- Interview with the PI and study coordinator
- Evidence evaluation
- Identification and classification of findings
0228 JanThu · 16:00 CET TMF and eTMF AuditsAssess TMF completeness, quality, timeliness and trial reconstructabilityExpert: Kimberly Prabhu
eLearning modules
- TMF reference model
- Essential records under ICH E6(R3)
- TMF plan
- Filing timeliness
- Quality control
- Metadata and audit trails
- Access management
- Certified copies
- Sponsor–CRO TMF reconciliation
- TMF close-out
Live practice webinar · 3 h
TMF Gap-Analysis Workshop
- Review of a simulated eTMF index
- Identification of missing, late and misfiled records
- Assessment of systemic TMF deficiencies
- Drafting findings
0304 FebThu · 16:00 CET Study-Level and Sponsor Oversight AuditsEvaluate end-to-end sponsor governance and oversight of a clinical trialExpert: Kimberly Prabhu
eLearning modules
- Study-level audit methodology
- Sponsor responsibilities
- Transfer of activities
- Governance structure
- Oversight plans
- Issue escalation
- Protocol deviations
- Safety and data interfaces
- Decision documentation
- Inspection readiness
Live practice webinar · 3 h
Sponsor Oversight Audit Simulation
- Mapping delegated activities
- Testing oversight evidence
- Reviewing governance minutes and metrics
- Identifying gaps in sponsor control
0411 FebThu · 16:00 CET CRO and Service Provider AuditsAudit CRO capabilities, qualification and ongoing performanceExpert: Kimberly Prabhu
eLearning modules
- Vendor risk classification
- Due diligence
- Qualification audits
- Contracts and quality agreements
- KPIs and quality metrics
- Subcontractor oversight
- Escalation
- CAPA management
- Requalification
- Vendor termination and transition
Live practice webinar · 3 h
CRO Qualification and Oversight Workshop
- Evaluation of a CRO qualification package
- Interview with CRO management
- Assessment of subcontractors
- Qualification decision and risk-based recommendations
0518 FebThu · 16:00 CET Clinical Laboratory and Bioanalytical AuditsAudit laboratories supporting clinical trials and assess sample and data integrityExpert: Orit Galperin
eLearning modules
- Laboratory organisation and QMS
- Sample collection and chain of custody
- Sample receipt, storage and disposal
- Method validation
- Equipment and systems
- Reagents and reference standards
- Deviations
- Data integrity
- Result reporting
- Sponsor oversight
Live practice webinar · 3 h
Laboratory Audit Case Study
- Trace a sample from collection to reported result
- Review laboratory records and audit trails
- Detect data-integrity risks
- Draft evidence-based findings
0625 FebThu · 16:00 CET Bioequivalence Study AuditsAudit the clinical, bioanalytical and statistical phases of bioequivalence studiesExpert: Bioequivalence Audit Expert · to be announced
eLearning modules
- BE study design
- Subject eligibility
- Dosing and confinement
- Sample collection
- Sample processing and transfer
- Bioanalytical phase
- Pharmacokinetic analysis
- Statistical evaluation
- Data reconciliation
- Study-report traceability
Live practice webinar · 3 h
End-to-End Bioequivalence Audit
- Review of clinical and analytical case files
- Reconstruction of the sample lifecycle
- Identification of timing and traceability issues
- Assessment of their impact
0704 MarThu · 16:00 CET Pharmacovigilance and Clinical Safety AuditsEvaluate safety-reporting processes and interfaces within clinical developmentExpert: Pharmacovigilance Auditor · to be announced
eLearning modules
- AE and SAE collection
- Investigator-to-sponsor reporting
- SUSAR assessment
- Expedited reporting
- Safety database controls
- Medical review
- Reconciliation
- Reference safety information
- Safety committees
- Vendor oversight
- Signal escalation
Live practice webinar · 3 h
Safety Reconciliation Audit Workshop
- Comparison of clinical and safety datasets
- Assessment of missing and late cases
- Review of reporting decisions
- Classification of safety findings
0811 MarThu · 16:00 CET Clinical Data Management and Biostatistics AuditsAudit the integrity and traceability of clinical data from collection to analysisExpert: Ravi Shah
eLearning modules
- Data-management plan
- Database design and validation
- Edit checks
- Query management
- Medical coding
- External data transfers
- Reconciliation
- Database lock
- Statistical analysis plan
- Programming controls
- SDTM/ADaM traceability
Live practice webinar · 3 h
Database Lock Readiness Audit
- Review of data-flow documentation
- Evaluation of open queries and reconciliations
- Testing database-lock controls
- Traceability from source data to analysis output
0918 MarThu · 16:00 CET Computerised Systems, CSV and Data Integrity AuditsEvaluate validated state, data integrity and regulatory compliance of clinical systemsExpert: CSV/Data Integrity Auditor · to be announced
eLearning modules
- Risk-based validation
- System lifecycle
- User requirements
- Supplier assessment
- Configuration and testing
- Access controls
- Audit trails
- Electronic signatures
- Data migration
- Backup and recovery
- Periodic review
- System retirement
Live practice webinar · 3 h
Clinical System Audit Simulation
- Audit of a simulated EDC, CTMS, eTMF or IRT system
- Review of validation evidence
- Audit-trail assessment
- User-access testing
- Drafting system findings
1025 MarThu · 16:00 CET RBQM and Centralised Monitoring AuditsAudit whether risk-based quality management operates effectively throughout the trialExpert: RBQM and Centralised Monitoring Expert · to be announced
eLearning modules
- Critical-to-quality factors
- Risk assessment
- RACT
- Monitoring strategy
- KRIs
- Quality tolerance limits
- Centralised monitoring
- Signal review
- Issue escalation
- Risk adaptation
- Documentation of decisions
- Effectiveness assessment
Live practice webinar · 3 h
RBQM Effectiveness Audit
- Review of a study risk assessment and monitoring plan
- Analysis of KRI and QTL signals
- Evaluation of escalation decisions
- Identification of “dashboard-only” compliance
1101 AprThu · 16:00 CEST Remote, Hybrid and Decentralised Trial AuditsPlan and conduct defensible audits in technology-enabled and decentralised environmentsExpert: Remote/DCT Audit Expert · to be announced
eLearning modules
- Remote-audit feasibility
- Hybrid audit design
- Secure document access
- Remote interviews
- Evidence authenticity
- Screen sharing and demonstrations
- DCT vendors
- Telemedicine
- eConsent
- Direct-to-patient IMP
- Wearables and connected devices
Live practice webinar · 3 h
Remote and DCT Audit Simulation
- Remote opening meeting
- Virtual facility and system demonstration
- Remote interviews
- Evidence limitations
- Decision to extend, convert or follow up the audit on site
1208 AprThu · 16:00 CEST AI-Assisted Auditing and Advanced CapstoneApply AI responsibly and demonstrate integrated advanced-auditing competenceExpert: Lead GCP Auditor and AI Validation Expert · to be announced
eLearning modules
- AI use cases in audit planning and document review
- AI risk assessment
- Validation and verification
- Confidentiality
- Prompt and output control
- Hallucination risk
- Traceability
- Human accountability
- Capstone case preparation
Live practice webinar · 3 h
Advanced Audit Capstone
- End-to-end multidisciplinary case
- Risk assessment
- Document review
- Interviews
- AI-supported evidence analysis
- Finding classification
- Closing meeting and management presentation
Same proven format, more advanced content
The Advanced School follows the format of our foundation GCP Auditor School: weekly eLearning, a live expert session and a cohort that learns together.
21 January – 8 April 2027, plus the final exam on 15 April
Every Thursday 16:00–19:00 CET on Zoom, recorded for review
Weekly self-paced eLearning on The QARP Academy platform
Participants per cohort for breakout work and personal feedback
eLearning modules
Work through the week's modules, regulatory references and case materials at your own pace.
Live audit simulation
Three hours with the lead expert: review the evidence, interview the auditee, classify findings.
Review and discussion
Session recording, assignment feedback and cohort discussion on the platform.
All times are Central European Time. Europe moves to summer time on 28 March 2027; sessions from 1 April stay at 16:00 local Central European time (CEST).
Learn from specialist auditors
Each domain is led by an auditor who audits that area in practice.
Dr Maxim Bunimovich
Founder & Director; GCP Auditor and Trainer, The QARP (Barcelona, Spain)
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.
Satyam Kothari
Director, ComplyWell Solutions (India)
Week 1 · Investigator sitesSatyam 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.
Kimberly Prabhu
Principal, KRP Scientific Inc. (USA)
Weeks 2–4 · TMF, sponsor, CROKimberly Prabhu is a clinical operations, clinical science and quality executive with more than 20 years of Phase I–IV experience across drugs, medical devices and combination products. She has managed more than 100 clinical trials, led more than 160 investigator site audits and 62 CRO qualification audits, and served as primary inspection lead for FDA, MHRA and Health Canada inspections that closed with zero findings. She is a Certified GCP Auditor with The QARP and designs training on ICH E6(R3), GCLP, ISO 14155 and 21 CFR Parts 11 and 812.
Orit Galperin
Founder & Director, Global Pharma QA
Week 5 · Clinical labsSenior Quality Assurance auditor and trainer with 21 years of experience in GLP/GCLP quality assurance for preclinical and clinical research. She has conducted more than 650 audits worldwide, covering bioanalytical and clinical laboratories, preclinical facilities, CROs and other service providers. Her expertise includes laboratory quality systems, bioanalytical method validation, sample analysis, data integrity and computerised systems validation. She has helped organisations achieve OECD-GLP accreditation and prepare for regulatory inspections, including through senior QA roles at Teva Pharmaceutical Industries and Pharmaseed. As Founder and Director of Global Pharma QA, she provides specialist GLP/GCLP training and mentoring for laboratory and quality professionals. At the Advanced GCP Auditor School, she brings a practical laboratory-auditing perspective, helping participants connect laboratory processes, sample traceability and data reliability with evidence-based audit findings.
Ravi Shah
Principal Consultant, ComplyWell Solutions (India)
Week 8 · Data managementAs 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.
Experts for bioequivalence, pharmacovigilance, CSV, RBQM, remote/DCT and AI-assisted auditing will be announced soon.
€2,500 per participant
Pay in full or split the fee into three payments. Your seat is confirmed after the first payment.
3 instalments
Total €2,500, split into three payments
- All 12 modules and 12 live simulations
- Session recordings and course materials
- Final exam and certificate
Full payment
One payment, no further instalments
- Everything in the instalment plan
- Seat confirmed immediately
- One invoice for your company
Four steps to your seat
Places are limited to 30 participants per cohort.
Apply
Submit the application form and tell us about your audit experience.
Eligibility check
We confirm your audit background. If needed, we invite you to a 15-minute interview.
Payment
Pay in full or make the first of three payments to secure your seat.
Start learning
Get platform access and join the first live session on Thursday, 21 January 2027.
Apply for the Advanced Auditor School 2027
30 places · 12 Thursdays at 16:00 CET · starts 21 January 2027 · final exam 15 April 2027
- 1Submit the form. It takes about two minutes.
- 2We review your audit experience and contact you if an interview is needed.
- 3You receive a payment link for full payment or for the first instalment.
Submitting the form does not by itself count as registration and does not guarantee a place in the group.
Your details
It takes about two minutes.
Please also read the Public Offer Agreement
Please fill in all required fields and accept the Terms and the Privacy Policy.
Your audit experience
The Advanced School is built for practising auditors.
Please select your audit experience and answer the graduate question.
The programme
12 audit domains in 12 Thursdays, 21 January – 8 April 2027, 16:00–19:00 CET (CEST from 1 April). Final exam on 15 April 2027.
Secure your seat
Places are limited to 30 participants. Your seat is confirmed after the first payment.
Enrolling through your company?
Let's Talk First
With less than one year of hands-on audit experience, we would like to talk to you before enrolment. Book a short admission interview, or start with our foundation programme.
New to GCP auditing? See the GCP Auditor School (foundation) →
Frequently asked questions
Do I need to complete the GCP Auditor School first?
No. The Advanced School is open to auditors with at least one year of hands-on audit experience. Graduates of the GCP Auditor School are eligible automatically.
What if I have less than one year of audit experience?
We recommend starting with the foundation GCP Auditor School. If your background is close, we may invite you to a short admission interview.
When are the live sessions?
Every Thursday from 21 January to 8 April 2027, 16:00–19:00 Central European Time. The final exam is on Thursday, 15 April 2027. All sessions are recorded.
How do the three payments work?
The first payment of €900 secures your seat. The remaining €1,600 is paid in two payments of €800. The total is the same €2,500.
Can my company pay?
Yes. Request an invoice or a signed training agreement, and we will prepare documents for your organisation.
I am a GCP Auditor School graduate. What changes in the Advanced School?
The foundation school covers the full audit cycle. The Advanced School goes deeper into 12 specialist audit types, and every live session is a practical audit simulation on a complex case.
Ready to audit the complex?
The Advanced Auditor School starts on Thursday, 21 January 2027. Places are limited to 30 participants.