Introduzione
Auditing and Supplier Quality Management
Effective supplier quality management goes far beyond performing an initial audit. Organisations must establish a structured and risk-based process to select, qualify, approve, monitor and periodically reassess suppliers and outsourced service providers throughout the relationship.
This course combines practical auditing principles with the key elements of supplier and outsourced activity management. Participants will learn how to establish a risk-based supplier qualification strategy, determine when audits are required, prepare and conduct effective audits, communicate findings, and ensure appropriate follow-up.
The course also addresses Quality Technical Agreements, supplier performance monitoring, corrective actions, requalification and ongoing oversight, providing participants with an integrated view of the supplier quality lifecycle. The underlying approach is risk-based: the level of qualification, audit and monitoring should reflect the supplier's potential impact on product quality, patient safety and regulatory compliance.
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Fundamentals of Auditing
- Purpose and principles of quality audits
- Audits as tools for compliance, effectiveness and continuous improvement
- Risk-based audit planning and audit programmes
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Preparing and Conducting an Audit
- Audit scope, criteria and preparation
- Auditor roles, competence and communication skills
- Opening and closing meetings
- Collection and assessment of objective evidence
- Identification and classification of observations
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Audit Reporting and Follow-up
- Communicating audit results effectively
- Risk-based prioritisation of findings
- Corrective actions, CAPA and follow-up
- Audit closure and management review
The source audit material presents auditing as a full cycle from planning and preparation through execution, reporting, closeout, CAPA and management review.
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Supplier Qualification and Approval
- Supplier selection and preliminary assessment
- Risk-based supplier classification
- Qualification tools: questionnaires, documentation review and audits
- Approval, disqualification and requalification
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Managing Outsourced Activities
- Responsibilities of the Contract Giver and Contract Acceptor
- Qualification before starting outsourced activities
- Managing deviations and supplier corrective actions
- Ongoing oversight of contracted services
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Quality Technical Agreements
- Purpose and role of Quality Technical Agreements
- Definition of quality and technical responsibilities
- Key areas to address in supplier and contractor agreements
- Change notification, subcontracting, deviations and regulatory inspections
- Review, approval and lifecycle management
The QTA material specifically emphasises clear allocation of responsibilities, change notification, subcontractor control, Data Integrity, non-conformance handling and communication of regulatory inspection outcomes.
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Supplier Performance Monitoring
- Risk-based monitoring of approved suppliers
- Quality, compliance and delivery performance
- Deviations, complaints and CAPAs
- Changes in supplier status or regulatory standing
- Determining when additional oversight or requalification is required
Performance monitoring is explicitly linked to supplier risk tier and can trigger increased oversight or requalification when performance deteriorates or significant changes occur.
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Practical Workshop
- Supplier risk assessment and qualification strategy
- Audit preparation and assessment of audit findings
- Review of supplier quality issues
- Determining appropriate CAPA, monitoring and requalification actions
- Identification of key elements for a Quality Technical Agreement
This course is designed for professionals involved in supplier qualification, auditing, supplier oversight and outsourced GMP activities.
It is relevant both for professionals who are starting to participate in supplier audits and qualification activities and for experienced personnel looking to strengthen the integration between auditing and supplier quality management.
The course is particularly suitable for:
- Quality Assurance and Supplier Quality professionals
- Internal and external auditors
- Procurement and Supply Chain personnel involved in supplier qualification
- Quality Control professionals
- Manufacturing and Operations personnel
- Regulatory Compliance professionals
- Technical Operations and Engineering personnel
- Contract Manufacturing and Outsourcing managers
- Professionals responsible for Quality Technical Agreements
- Subject Matter Experts involved in supplier audits
Participant Experience
A basic understanding of GMP and pharmaceutical quality systems is recommended.
Previous auditing experience is useful but not required. The course is suitable both for professionals beginning to participate in supplier audits and qualification activities and for experienced personnel who want to strengthen the integration between auditing and supplier quality management.
This is an interactive, instructor-led training course with practical exercises.
Teaching methods include regulatory and quality-system concepts, practical examples, audit scenarios, supplier qualification exercises, risk assessment, review of supplier performance information, audit-reporting exercises and discussion of Quality Technical Agreements.
The focus is not only on how to perform an audit, but on how audit outcomes should feed into broader supplier qualification, CAPA, monitoring and requalification decisions.
Docente/i
Andrés Gola Isasi
Andres Gola Isasi is a Life Science Regulatory Compliance professional with extensive experience in the pharmaceutical, biotechnology and medical device industries. His expertise covers Regulatory Affairs, Quality Assurance, GMP compliance, investigations, Root Cause Analysis, CAPA systems, Human Factors and regulatory inspections.
Throughout his career, he has supported international life science organisations in quality and regulatory projects, including deviation investigations, CAPA improvement, inspection readiness, remediation activities and quality-system optimisation. He also combines his consulting experience with university teaching and professional training in Regulatory Affairs, Quality and Project Management.
Online Training – 2 modules
MODULE 1 | 16 November 2027 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 18 November 2027 from 2:30 pm to 5:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 26 October 2027)
Ordinary: € 885,00*
Freelance – Individual – Academy – Public Administration**: € 495,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Metodi di pagamento accettati: Bonifico bancario, Carta di credito, PayPal.
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.