Course overview
The integration of Artificial Intelligence (AI) and Machine Learning (ML) into the Good Manufacturing Practice (GMP) environment represents a profound shift in pharmaceutical quality management. No longer confined to theoretical or discovery applications, AI technologies are actively restructuring manufacturing, automated quality control, and predictive quality assurance. However, moving from traditional rule-based computerized systems to dynamic, data-driven AI systems introduces complex challenges to established GxP pillars: reproducibility, traceability, and absolute control.
This intensive, masterclass-level training program is specifically engineered for senior quality assurance professionals, lead auditors, and regulatory compliance managers. It bridges the gap between advanced data science and practical GMP compliance, heavily grounded in the latest regulatory expectations, including the 2026 FDA-EMA Joint Guiding Principles of Good AI Practice in Drug Development, the evolving EU GMP Annex 11 revision concepts, and the EU AI Act.
Rather than treating AI as a ‘black box,’ this course provides a systematic framework to validate, audit, and govern AI technologies safely within a Risk-Based Quality Management System (QMS), shifting an organisation's capability from retroactive error finding to proactive error prevention.
By the end of this course, participants will be able to:
- Decode Regulatory Expectations: Interpret and apply the latest 2026 FDA/EMA joint principles and GxP expectations regarding AI system lifecycles
- Establish Robust Governance: Implement internal AI governance frameworks that define clear ‘Human-in-the-Loop’ (HITL) and ‘Human-on-the-Loop’ (HOTL) boundary controls
- Validate Non-Linear Systems: Adapt traditional Computerized System Validation (CSV) workflows into modern Software Validation / Learning Assurance frameworks suited for AI algorithms
- Audit with Confidence: Conduct targeted internal and vendor audits on data lineage, Retrieval-Augmented Generation (RAG) security, and algorithm drift
- Optimise Quality Workflows: Securely leverage Generative AI (GPT platforms) to accelerate deviation handling, Root Cause Analysis (RCA), and Supplier Notifications of Change (SNC)
CPD Hours: 6
Course Content
- Day 1
- Context-setting and the paradigm shift
- The regulatory landscape for AI in GxP (2025-2026)
- AI Validation, data integrity and algorithm lifecycle management
- Practical implementation - GenAI & Machine Learning in QA/QC
- Risk management and auditing AI vendors/systems
- Interactive practicum & case studies
- Panel discussion, Q&A, and closing remarks
Speakers
Mustafa Edik
Mustafa Edik is a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.
As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.
His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.
Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:
- GMP/GDP audits and supplier qualification
- Validation, qualification, and quality risk management (ICH Q9)
- Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
- Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
- Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
- Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards
Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.
A prolific author, Mustafa's works include:
- “Sorularla GMP Dokümantasyonu” - a practical guide to GMP documentation
- “GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) - a comprehensive reference on effective GMP auditing practices
Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.
