Part of Audit Essentials: From Interviews to Inspections series:

Led by industry expert Mustafa Edik, this comprehensive new training series is designed for professionals in the pharmaceutical industry who want to master GMP audits. Learn how to conduct thorough audits, manage supplier assessments, and confidently handle regulatory inspections. The courses in this series cover everything from raw material audits and GMP compliance to overcoming challenges and maintaining audit readiness for major health authorities like the FDA, EMA, and WHO. Additionally, you’ll gain crucial knowledge of Good Distribution Practices (GDP) and Good Storage Practices (GSP) to ensure product quality and safety. Ready to elevate your auditing expertise and stay ahead of industry standards? Enrol today!

Course overview

This intensive two-day training course will equip you with the essential skills and knowledge needed to effectively plan, manage, and execute internal GMP audits. As part of the pharmaceutical industry’s commitment to producing safe and effective products, Good Manufacturing Practices (GMP) audits are crucial for maintaining compliance with regulatory standards and ensuring product quality. Internal GMP audits play a vital role in identifying potential risks, ensuring manufacturing processes adhere to the highest quality standards, and preparing your organisation for external regulatory inspections.

Whether you’re new to auditing or looking to refine your existing processes, this programme will provide you with the tools needed to conduct thorough audits that assess compliance, identify non-conformities, and drive continuous improvement within your organisation.

By the end of this training, you will be able to confidently manage internal GMP audits, ensuring your company consistently meets regulatory requirements and maintains the highest levels of product quality and safety.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Gain an understanding of the internal audit process, from planning and execution to reporting and follow-up
Learn how to establish a structured internal audit program that aligns with GMP requirements
Develop skills to create effective audit plans, define audit scope, and prioritise areas of focus based on risk and criticality, ensuring audits are thorough and efficient
Strengthen your ability to identify non-conformities, assess risks, and mitigate potential issues before they escalate.
Understand how to evaluate audit findings and develop actionable corrective and preventive action (CAPA) plans.
Identify ways to streamline the internal audit process, saving time and resources while maintaining a high level of audit quality

Who should attend

This training will benefit those in the following departments:

Quality Assurance
Quality Control
GMP Compliance
Auditing
IT
Regulatory Affairs
Engineering
Supply Chain

This course will cover:

Day 1
Day 2

Introduction to internal GMP audits

Overview of Good Manufacturing Practices (GMP) and their importance
Role of internal audits in ensuring compliance and continuous improvement
Key components of an internal GMP audit program

The role of internal audits in compliance and risk management

How internal audits help identify risks and prevent compliance issues
Aligning audits with regulatory requirements (FDA, EMA, WHO)
Identifying critical GMP areas to focus on during audits

Planning for internal GMP audits

Defining audit scope, objectives, and goals
Risk-based approach to selecting areas for auditing
Preparing audit checklists and audit tools
Assigning roles and responsibilities within the audit team

Managing the audit process – best practices

The key stages of an internal audit (planning, execution, reporting, follow-up)
Preparing for the audit: document review and information gathering
How to lead an audit team and maintain objectivity
Conducting effective interviews and observations

Workshop - risk management practices in internal audit plan preparation

Conducting the internal GMP audit

Techniques for effective onsite auditing
Identifying and evaluating non-conformities and compliance gaps
Assessing facilities, equipment, and manufacturing processes
Effective ways of interacting with staff and departments during the audit

Documenting audit findings and reporting

How to document audit findings accurately and clearly
Best practices for audit reporting: structuring and presenting results
Ensuring transparency and objectivity in audit reports
Reporting non-conformities, risks, and recommendations

Corrective and preventive actions (CAPA)

Identifying root causes of non-conformities
Developing effective corrective actions and preventive measures
Working with departments to implement CAPA plans
Verifying the implementation and effectiveness of CAPA

Post-audit follow-up and continuous improvement

How to track progress on CAPA implementation
Maintaining audit records and documentation for future reference
Using audit results to foster a culture of continuous improvement
Leveraging audits as a tool for enhancing quality and compliance

Managing challenging audit scenarios

Handling resistance to audits and managing difficult auditees
Navigating complex audits in high-risk areas
How to manage audits in areas with a prior non-compliance history
Dealing with audit failures and challenging findings

Workshop - risks of opening and closing meetings of internal audits

Hands-on exercise: Conducting a mock internal GMP audit

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.

More details

Run How to Manage Internal GMP Audits Live online for your team

Pricing from:

GBP 1,000

Per attendee, based on 10 attendees
Course tailored to your requirements
At your choice of location, or online

Contact us

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our team to discuss your requirements:

How to Manage Internal GMP (Good Manufacturing Practice) Audits In-house Training