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
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.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Mustafa Edik,
Independent GMP Consultant and AuditorAfter 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.
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
