Presented by
Management Forum
How to Audit Pharmaceutical Suppliers (Material and Service) Training Course
This training provides knowledge and practical skills to effectively audit material and service providers, covering key areas including raw materials, contract manufacturing, logistics, and packaging.
26-27 June 2025
+ 24-25 September 2025, 26-27 February 2026 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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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. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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
This course will cover:
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
Mustafa Edik
Mustafa Edik is an Independent GMP Consultant and Auditor.
After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.
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
26-27 June 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15620
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 22 May
- 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
Not ready to book yet?
for 7 days, no obligation
24-25 September 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15621
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 20 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
Not ready to book yet?
for 7 days, no obligation
26-27 February 2026
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15622
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 22 Jan
- 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
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.
Run How to Audit Pharmaceutical Suppliers (Material and Service) 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
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 in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
