Presented by
Management Forum
Best Practices for Supplier Qualification in Life Science In-house Training
Optimize 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.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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
This course will cover:
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.
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 he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
