Course overview
Over the past decade, data integrity has become the number one focus in regulatory inspections - and it’s showing no signs of slowing down. While the topic has only recently taken centre stage, its roots stretch back 30 years, with early breaches at Barr Laboratories and Able highlighting just how long-standing and serious the issue truly is.
As health authorities continue to scrutinise data integrity during audits, especially GMP audits, pharmaceutical manufacturers are under increasing pressure to ensure their internal teams are well prepared.
This intensive two-day course, delivered through practical guidance and real-world examples, explores data integrity through the lens of GxP audits. You’ll gain a clear understanding of regulatory expectations, the core concepts and guidelines, and what auditors need to know to uncover deficiencies before the authorities do.
Participants will explore which departments require data integrity auditing - from warehouse and production to quality control, quality assurance, engineering, and critical utilities. Sample audit questions, common findings, and real case studies bring the learning to life, ensuring you leave equipped to carry out confident, effective audits.
Whether you're building an audit-ready culture or sharpening your team’s inspection-readiness, this course will give you the tools and insight to make a measurable impact.
CPD Hours: 12
Course Content
- Day 1
- Welcome and introduction
- GMP guidelines and regulations for data integrity (DI)
- Data integrity principles
- Data integrity Issues in pharmaceutical companies
- FDA's pre-approval inspection (PAI) and data integrity issues
- Audit planning and team building
- Hints, tips and clues to performing successful DI audits
- Virtual DI audits
- Workshop 1: data Integrity sourcing to laboratory equipment
- Day 2
- Recap of day one
- DI auditing of warehouse and critical utilities
- DI auditing of manufacturing
- DI auditing of an analytical chemistry laboratory
- DI auditing of a microbiology laboratory
- Supplier DI auditing
- Electronic records and electronic signatures (ERES) DI auditing
- IT Infrastructure and cloud DI auditing
- Workshop 2: data falsification investigation
- DI audit report preparation and distribution
- Case Studies and lessons learnt from regulatory inspections
- Exam
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.
