A free, live 90-minute webinar on how to connect key ISO 13485 processes and demonstrate inspection readiness with clear, traceable evidence.
An inspection-ready quality management system requires more than approved procedures. Organisations must demonstrate that their processes work together and that decisions, actions and results are supported by clear evidence.
In this practical webinar, Pourya Vali will explore how to connect key ISO 13485 QMS processes, including supplier management, manufacturing controls, validation, nonconformities, CAPA, internal audits and management review. A supplier-change case study will illustrate how to maintain traceability across functions and identify gaps before an audit or inspection.
Participants will receive a practical QMS Inspection Readiness Checklist to help assess process connections, evidence availability and priority actions.
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Connect ISO 13485 processes through clear responsibilities, risk management and documented evidence. - Strengthen supplier oversight, manufacturing controls and risk-based process and software validation.
- Manage nonconformities and CAPA effectively, from investigation and root cause to effectiveness checks.
- Trace a supplier change across functions and identify evidence gaps before an audit or inspection.
- Use the QMS Inspection Readiness Checklist to prioritise actions in your own organisation.
- Responsibilities, risk management and documented evidence
- Supplier oversight and manufacturing controls
- Risk-based process and software validation
- Investigation and root cause
- Effectiveness checks
- Following a supplier change through risk assessment, validation, documentation and training
- Internal audits and management review
- The QMS Inspection Readiness Checklist
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Who Should Attend
- QA professionals in medical-device organisations
- QMS process owners
- Quality and operations managers
- Supplier quality and manufacturing quality specialists
- Anyone preparing for an ISO 13485 audit or regulatory inspection
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Participant Takeaway
All participants will receive the QMS Inspection Readiness Checklist, a practical tool for assessing process connections, evidence availability and priority actions.
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Want to go deeper? Explore Pourya's course Medical Devices Regulation in EU and USA, The QARP Academy
Add the device-specific layer to the GxP knowledge you already have. The course covers ISO 13485, MDR/IVDR and FDA device pathways, risk management and device-specific audit preparation, all worked through on real audit scenarios.
- Self-paced online course in English: 6 modules, 42 lessons
- Certificate on completion
- Corporate licences: [email protected]
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- Pourya ValiFounder & Principal Consultant, Nordic GxP Compliance; Lead Auditor in GxP and ISO 13485Pourya is a quality assurance expert with over 13 years of experience across GMP, GxP and medical-device environments, including combination products. He is a certified Lead Auditor in GxP and ISO 13485. His work focuses on audits, inspection readiness, CAPA, change control, validation and supplier and CMO quality oversight. He has held senior QA and lead auditor roles in the pharmaceutical and medical-device industries, including PRRC responsibility and CMO quality oversight. He is known for a pragmatic, risk-based approach that bridges the gap between regulatory expectations and operational reality. Pourya is also the author of The QARP Academy course Medical Devices Regulation in EU and USA.
Group Registration: We encourage teams to attend together. Contact us for assistance with multiple registrations.
- Q:Is this webinar really free?A:Yes, this is a complimentary educational session with no cost to attend.
- Q:Will the webinar be recorded?A:Yes, a recording will be available to all registered participants after the live event.
- Q:What platform will be used?A:The webinar will be hosted on Zoom. Login details will be sent before the webinar.
- Q:Can I ask questions during the session?A:Absolutely. 30 minutes are dedicated to live Q&A and discussion.
- Q:Will I receive any materials?A:Yes, all participants will receive the QMS Inspection Readiness Checklist.