Presented by
Management Forum
Advanced GMP (Good Manufacturing Practice) & GDP Auditor Masterclass Training Course
An intensive three-day master class designed to develop advanced GMP & GDP auditing skills for managing evolving regulations, complex supply chains, and high-risk pharmaceutical operations.
2-4 November 2026
+ 10-12 May 2027 »
from £1599
- Format: Live online
- CPD: 18 hours for your records
- Certificate of completion
Course overview
In the highly regulated pharmaceutical and life sciences industries, patient safety and product efficacy depend entirely on the integrity of the manufacturing and supply chain processes. Compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) is not merely a legal checkbox; it is a critical operational standard that safeguards global health.
This comprehensive, three-day master class is designed to transform industry professionals into elite, forward-thinking auditors. Delivered by expert trainer, Mustafa Edik, this course bridges the gap between theoretical regulatory text and hard-hitting, real-world inspection strategies.
The landscape of pharmaceutical regulation is evolving at a breakneck pace. With the recent, stringent overhauls of EU/PIC/S GMP Annex 1 (Sterile Manufacturing), the global push toward automated technologies under Annex 11, and the heightened scrutiny on Data Integrity (DI), standard auditing checklists are no longer sufficient.
Furthermore, international cross-border supply chains have become incredibly complex. Moving a product from raw Active Pharmaceutical Ingredients (APIs) to the patient’s bedside requires flawless oversight of contract manufacturers, third-party logistics (3PL) providers, and multi-modal cold chain transportation networks. This course equips you with the strategic mindset and tactical tools required to identify vulnerabilities before regulatory authorities do.
This master class is meticulously structured around four critical dimensions of pharmaceutical quality oversight:
- Global Regulatory Harmonization: Mastery over the overlapping and distinct requirements of major health authorities, including the FDA (USA), EMA / EU GMP, TİTCK (Turkey), and PIC/S frameworks. You will learn to navigate ICH guidelines
- Risk Management
- Quality Systems
- Analytical Procedure Development, and
- Stability
- The Auditor Mindset: Shifting from a ‘policeman’ auditing style to a constructive, risk-based investigator. You will learn how to build an objective audit scope, manage team dynamics, and handle high-pressure scenarios, such as opening/closing meetings and challenging corporate cultures.
- Specialised Technical Competence: Moving beyond basic warehouse and facility walkthroughs. You will deep-dive into advanced technical auditing, including qualifying API/excipient suppliers, validating complex computerised systems, and inspecting high-tech biotechnology facilities (e.g., mRNA vaccine lines, Monoclonal Antibodies (mAbs), and blood products).
- Defensive CAPA & Crisis Management: Understanding how to respond to critical non-conformances, FDA Form 483s, or official warning letters. You will learn the mechanics of bulletproof Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) tracking to satisfy international inspectors.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.
Benefits of attending
- Develop an elite, risk-based investigator mindset for managing complex audit dynamics
- Master auditing of automated systems, data integrity frameworks, and global distribution networks
- Gain practical understanding of FDA, EMA/EU GMP, PIC/S, and TİTCK regulatory expectations
- Apply advanced ICH guidelines across risk management, quality systems, analytical procedures, and stability
- Identify quality, compliance, and data integrity vulnerabilities before regulatory inspections
- Ensure effective oversight of cold chain logistics, CMOs, CDMOs, and complex supply chains
- Maintain readiness for evolving EU/PIC/S GMP Annex 1 and global data integrity requirements
- Maximise audit efficiency by focusing resources on critical high-risk technical areas
Who should attend
This course is designed specifically for mid-to-senior level professionals looking to achieve or renew
- Quality Assurance (QA) Directors, Managers, and Specialists
- Quality Control (QC) Laboratory Heads
- Qualified Persons (QPs) and Responsible Persons (RPs)
- Regulatory Affairs Professionals
- Supply Chain, Logistics, and Vendor Qualification Managers
- Pharma Consultants and Independent Auditors
This course will cover:
Introduction to quality systems
- Defining quality vs. price, cost, and design in the pharmaceutical landscape
Quality management models and global regulations
- Adapting international quality benchmarks to modern pharma
- Overview of the ISO 9000 series, ISO 9001 standard implementation, and complementary quality models
- EU GMP, and PIC/S guidelines
Pharmaceutical QMS and GMP synergy
- Connecting corporate quality approach with standard operating practices
- Core elements of a Pharmaceutical Quality System (PQS) under ICH Q10
What is a GMP Audit?
- Defining audit definitions, scopes, criteria, and the underlying logic of compliance
The strategic necessity of auditing
- Why do we audit? Driving continuous process improvement instead of mere routine tracking
- Overview of contract manufacturing/analysis risk prevention and exporting safely to foreign markets
Wrap-up and evaluation
- Daily assessment to track the retention of foundational quality concepts
Roles, responsibilities, and audit preparation
- The Auditor’s mindset: selection of the audit team, defining timelines, and objective scoping
- Ethics, impact, and the balance of power in audits
Audit requirements and laboratory control
- Crucial tips for auditing Quality Control (QC) laboratories
Audit execution and post-audit action items
- Opening and closing meetings protocols, recording non-conformances, and generating the Audit Report
- Real-Life CAPA and follow-up management post-audit. Handling Form 483s, warning letters, responding to health authorities, and crisis management
Supplier auditing - APIs and excipients
- Deep dive into qualifying Active Pharmaceutical Ingredient (API) and excipient manufacturers
- Auditing experiences across diverse cultures and multinational companies. Overcoming language barriers, cultural misunderstandings, and distinct corporate behaviors between US, European, and Asian facilities.
Supplier auditing - packaging materials
- Audit strategies for qualifying primary and secondary packaging component suppliers
Wrap-up and evaluation
- Assessment checking knowledge on audit execution, supplier qualification, and CAPA logic
Computerised systems and data integrity (DI)
- Auditing automated processing networks, digital footprints, and software infrastructure
- Integrating EU GMP Annex 11 and FDA Computer Software Assurance (CSA) regulations
Deep dive into GDP and supply chain validations
- Auditing air, sea, and land cargo channels for pharmaceuticals
- Cold chain validation and transportation validation: ensuring stability and security throughout distribution channels
Special technical module: sterility and contamination control (EU/PIC/S Annex 1)
- Auditing sterile spaces, cleanroom classifications, cleanroom garment management, and cleaning/sterilization vendors
- Building and evaluating a Contamination Control Strategy (CCS) during inspections
High-tech and biotech facility inspections
- Audit blueprints for advanced manufacturing sites: Vaccine facilities (mRNA, subunit, protein-based), Monoclonal Antibodies (mAb) lines (from cell bank to finished vial), Blood/Plasma products, and Radiopharmaceuticals
- Integrating the latest ICH updates (ICH Q2, Q9(R1) Risk Management, Q14, and Q1A-Q1F Stability testing guidelines)
Future outlook: The next 5 years of GMP/GDP regulations
- Anticipated regulatory adaptations by EMA, FDA, and TİTCK.
Final masterclass evaluation
- Comprehensive evaluation covering all core topics of the 3-day class
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
Please contact us for pricing if you are interested in booking 5 or more delegates
2-4 November 2026
Live online
08:30-17:00 UK (London) (UTC+00)
09:30-18:00 Paris (UTC+01)
03:30-12:00 New York (UTC-05)
Course code 17603
- GBP 1,599 1,899
- EUR 2,239 2,659
- USD 2,571 3,039
Until 28 Sep
- 3 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
10-12 May 2027
Live online
08:30-17:00 UK (London) (UTC+01)
09:30-18:00 Paris (UTC+02)
03:30-12:00 New York (UTC-04)
Course code 17604
- GBP 1,599 1,899
- EUR 2,239 2,659
- USD 2,571 3,039
Until 05 Apr
- 3 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
