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

Ensuring the quality and compliance of suppliers is crucial to maintaining the safety and efficacy of products in the pharmaceutical industry. Supplier audits play a vital role in this process, as they assess whether material and service providers meet the stringent standards required for pharmaceutical manufacturing.

This training is designed to equip you with the knowledge and practical skills necessary to effectively conduct supplier audits, covering both materials and services. Whether you are responsible for auditing raw material suppliers, contract manufacturers, or service providers such as logistics and packaging suppliers, this programme will provide you with the tools to evaluate their processes, identify potential risks, and ensure compliance with regulatory requirements like Good Manufacturing Practices (GMP) and other industry standards.

By the end of this training, you will be better prepared to manage supplier relationships confidently, ensuring that all materials and services meet the highest industry standards, thereby protecting your company, products, and customers.

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

Gain a deep understanding of the purpose and scope of supplier audits in the pharmaceutical industry
Learn how to evaluate both material suppliers and service providers to ensure compliance with regulatory standards
Develop practical skills necessary to effectively plan, conduct, and document supplier audits
Discuss potential risks in the supply chain, including quality and safety concerns
Understand how to audit suppliers in alignment with international standards, reducing the risk of non-compliance
Navigate how to streamline the audit process, from planning to reporting
Master effective communication strategies for managing supplier audits, ensuring constructive feedback, and fostering a positive working relationship

Who should attend

This training will best suit those in the following departments:

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

Enrol/reserve

This course will cover:

Day 1
Day 2

Introduction to supplier audits in the pharmaceutical industry

Why supplier audits are critical in ensuring product quality and regulatory compliance
The role of supplier audits in risk management
Overview of the key types of suppliers: material suppliers, service providers, and contract manufacturers

Understanding regulatory requirements for supplier audits

Key regulations and standards: GMP (Good Manufacturing Practices), FDA, EMA, WHO, and ICH guidelines
Understanding the importance of supplier qualification and ongoing monitoring
Regulatory authority’s expectations for supplier audits and their role in the supply chain

Scope and planning

Defining the scope and objectives of an audit
How to select suppliers for auditing based on risk and criticality
Audit planning and creating audit checklists
Understanding the audit process: from pre-audit preparation to post-audit follow-up
How to prioritise audits based on risk (e.g., criticality of the product, supplier history, geographical location)
Risk management strategies: evaluating suppliers with a risk-based mindset
Techniques for focusing on high-risk areas during the audit

Auditing material suppliers – key focus areas

Key areas to evaluate in raw material suppliers (e.g., manufacturing processes, quality control, traceability)
Ensuring compliance with material specifications, storage conditions, and transportation
How to assess documentation and product testing reports
Identifying potential risks in the supply chain related to materials

Workshop – risk based API supplier audit plan and prioritisation rules

Practical, hands-on workshop where participants simulate a risk based (Active Pharmaceutical Ingredients) API supplier audit plan

Auditing service providers (logistics, packaging, contract manufacturers)

Evaluating service providers based on their impact on product quality and regulatory compliance
Focus areas: service quality, process control, staff training, and compliance with specific service requirements
How to evaluate contract manufacturers and other third-party service providers

Audit execution and on-site techniques

Conducting on-site audits: what to look for, how to ask the right questions
How to gather evidence, observe operations, and interview key personnel
Assessing facilities, equipment, and quality systems in place
Techniques for maintaining objectivity and consistency during the audit process

Identifying non-conformities and corrective actions

How to identify non-conformities during an audit
Best practices for reporting findings clearly and effectively
Developing corrective and preventive action (CAPA) plans with suppliers
How to manage supplier responses and follow-up audits to ensure compliance

Supplier relationship management and audit follow-up

Building strong supplier relationships to ensure long-term quality and compliance
Creating audit reports that foster collaboration rather than conflict
Handling audit findings diplomatically and developing mutually beneficial action plans
Importance of continuous supplier monitoring and periodic re-audits

Interactive workshop: how and according to which guidelines are audits of service providers carried out

Practical, hands-on workshop where participants discuss the best practices for auditing service providers

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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

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

14-15 September 2026

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Timings may be different for each day
Course code 16351

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 10 Aug

2 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

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* 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.

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Pricing from:

GBP 1,000

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

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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 Audit Pharmaceutical Suppliers (Material and Service) Training Course