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Best Practices for Supplier Qualification in Life Science Training Course

Optimise Regulatory Compliance and Supply Chain Efficiency through Expert Supplier Qualification Practices in Life Science.

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

★★★★★ "Since my experience in Quality Agreements is low, [I hoped to] learn more about Supplier Risk Assess... more"

6-7 May 2026
+ 12-13 November 2026 »
from £1299

Need help? Enrol/reserve

Course overview

Conduct thorough supplier qualifications and audits to strengthen the quality systems of your pharmaceutical, biotechnology, and medical device manufacturing processes.

Ensuring suppliers consistently meet quality requirements is paramount across all materials and services procured. Regulatory agencies such as FDA, EMA, MHRA, TGA, PIC/S, and ISO 13485 have intensified their focus on supplier qualification. The 2015 update of the EU GMP Guide notably emphasised supplier selection and qualification in Chapter 5, marking a significant regulatory shift.

While supplier qualification may have been unfamiliar decades ago, it has now become integral to industry practices. Qualifying suppliers, especially those in regions like China and India, presents unique challenges, demanding additional responsibilities for both parties. Beyond audits, establishing effective "Quality Agreements" is essential. Prior to outsourcing, companies must define minimum product specification and user requirements to ensure compliance with GMP standards. Each product may necessitate specific evaluation criteria during initial technical visits to potential supplier, involving assessment of SOPs, Quality Management Systems, previous audits, organisational structure, and task distribution.

This course equips participants with practical strategies to navigate complex supplier qualification processes, enhancing compliance, and optimizing quality management systems to meet stringent regulatory expectations. Delegates will gain comprehensive strategies and insights into conducting rigorous supplier qualification and audits to enhance the quality systems across pharmaceutical, biotechnology, and medical device manufacturing processes.

Bonus documents included:

Supplier qualification questionaries (API, excipient, packaging material)
Supplier evaluation matrix
Risk-based supplier audits
Quality Agreement
Supplier qualification sample SOP
FDA inspection findings, example warning letters, Form 483s
Warehouse, logistics service provider qualification documents

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

Learn supplier source search criteria
Understand key considerations in supplier selection
Develop skills in preparing supplier pre-evaluation questionnaires
Discuss strategies to overcome constraints in supplier audits
Formulate effective performance evaluations for suppliers
Gain insights into evaluating suppliers from different perspectives
Witness exemplary practices in pharmaceutical and medical device industries, exceeding health authority and GMP expectations.

Who should attend?

Professionals working in pharmaceuticals, biotechnology or medical devices, including:

Quality Assurance/Quality Control Specialists
GMP Compliance Officers
Validation Professionals
Engineering Personnel
Operation Staff
Manufacturing Professionals
Supply Chain
Logistics Staff
IT Personnel
Purchasing Managers

Enrol/reserve

This course will cover:

Day 1
Day 2

Supplier Qualification Introduction

What is supplier qualification?
- Why should qualification be done, who requires/expects It?
International guidelines and directives for supplier qualification
- Overview of legislation, health authority expectations
- International Trade Laws
Is the ISO 9001 certificate only sufficient for supplier qualification?
Why should the purchasing unit receive GMP training?
- What should be the scope of training?

Quality Management System and supplier qualification

What is change control?
How should deviations be managed?
How are complaints, recalls, and supplier qualification related?
What is the role and importance of purchasing in supplier qualification?
Can quality assurance, supplier, and purchasing cooperation be achieved?

Sampling and test reduction

What does reduced testing mean?
- What are the health authority expectations for reduced testing?
- What should be done before test reduction?

Raw materials and service providers

Should active pharmaceutical ingredients (APIs) and excipients be evaluated using the same method?
How to qualify service providers?

Medical device suppliers

Medical device supplier qualification process (21 CFR Part 820, MDR, GHTF, ISO 9001, ISO 1497, ISO 13485)
- PIP breast implant scandal

Flow of supplier qualification & documentation

How does the relationship between audits and supplier qualification begin?
Who performs qualification activities?
How do we know who does what – Manufacturer or Distributor?
How will we document our supplier qualification activities?
What is the qualification cycle?

Group exercise: Review of an existing supplier categorisation and evaluation study

Critique of format
Critique of content

Workshop: Supplier categorisation & evaluation

Breakout groups to review and suggest improvement in the selection of supplier categorisation and evaluations.

Supplier auditing

Why are audits necessary and critical?
- Risk-based audit planning.
- To audit or not to audit?
- What should the frequency of supplier audits be?
- Different approaches to different suppliers

Quality agreement preparation

What are Quality Agreements and why are they needed?
- What should and should not be included in quality agreements?
- Tips for negotiating an agreement.
- How to troubleshoot common deficiencies?
- Who prepares and approves the quality agreement? / Roles - What are the responsibilities?

Supply chain risk management

How should unexpected incidents be managed?
How to apply risk management in supply chain? Cases
What to consider when purchasing from Asian countries?
- How to overcome cultural difference problems in purchasing from India and China?
- How should we audit in India and China?
- What are the most common quality deficiencies?
- What is the latest situation of the pharmaceutical market in India and China? (Legal Requirements, Authority Approaches)
- What are the GMP violations in China and India?
- What about audits in Europe and Latin America?
Which documents are enough to make a company legal / illegal?
Supply chain risk mitigation strategies.
Supplier qualification and digital technologies

Group exercise: Review of an existing supplier Quality Agreement

Critique of format
Critique of content

Workshop: Supplier Quality Agreement

Breakout groups to review and suggest improvement in supplier quality agreement.

Enrol/reserve

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

6-7 May 2026

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 16265

GBP 1,499
EUR 2,099
USD 2,399

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

View basket

Not ready to book yet?

for 7 days, no obligation

12-13 November 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 16528

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

Until 08 Oct

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

View basket

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.

Reviews of IPI's Best Practices for Supplier Qualification in Life Science training course

Since my experience in Quality Agreements is low, [I hoped to] learn more about Supplier Risk Assessments, Supplier Qualification system and [especially] relevant Regulations. [I found] Content--> more than adequate. Presentation--> interactive and effective. Speaker--> accurate, helpful.

Mar 27 2025

Ifigeneia Panagou Greece
Quality Assurance Officer, Lavipharm SA