Conduct thorough supplier qualifications and audits to strengthen the quality systems of your pharmaceutical, biotechnology, and medical device manufacturing processes.
Best Practices for Supplier Qualification in Life Science Training Course
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
Course Content
Day 1
