Principles of Special Process Validation

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01

Course description

The foundation course in the Special Process Validation series, establishing the scientific and regulatory basis for validating sterilisation, cleanrooms and sterile packaging in medical device manufacturing. Covers the regulatory imperative of ISO 13485:2016 (Clause 7.5.6), validation life cycle methodology (IQ/OQ/PQ), the risk-based approach under ISO 14971:2019 and integration across FDA QMSR (21 CFR 820.75), EU MDR Annex I, MDSAP Chapter 5 and ANVISA RDC 751/2022.

02

Course objective

Equip participants to understand and apply the fundamental principles of special process validation, connecting hazard identification, challenge conditions and validation documentation for regulatory submissions. On completing the programme, professionals master IQ/OQ/PQ methodology, the Validation Master Plan and the interdependence of sterilisation, cleanrooms and packaging, and are prepared to defend validation documentation in ANVISA, FDA and European notified body audits.

03

Course programme

12h of in-depth learning
  1. 01

    Principles of Special Process Validation

    The regulatory imperative for special processes (ISO 13485:2016 Clause 7.5.6, FDA QMSR 820.75, EU MDR Annex I, MDSAP Chapter 5, ANVISA RDC 751/2022). Validation life cycle methodology: the IQ/OQ/PQ paradigm, Validation Master Plan (VMP), process characterisation, challenge conditions, statistical foundations and change control. A risk-based approach integrating ISO 14971:2019 and process FMEA.

    6h
  2. 02

    The Relationship between Sterilisation, Cleanrooms and Packaging

    Mapping interdependencies across the three domains: how cleanroom failures affect bioburden, sterilisation and packaging integrity. Integrated risk assessment using combined FMEA, process flow optimisation and the cascading effects of change control.

    2h
  3. 03

    Regulatory Deep Dive: Compliance across Multiple Frameworks

    FDA QMSR 21 CFR 820.75 (expectations, Form 483 observations and Warning Letters), EU MDR Annex I GSPRs, the MDSAP Chapter 5 audit approach, ANVISA RDC 751/2022 and a harmonised regulatory submission strategy (510(k), CE and ANVISA registration).

    2h
  4. 04

    Audit Readiness and Common Nonconformities

    The top 20 audit findings in sterilisation, cleanroom and packaging validation. A simulated audit scenario, CAPA effectiveness verification, management review of validation data (metrics, KPIs and trends), and auditing suppliers and contract manufacturers.

    2h

04

Who can attend?

  • Quality, Validation, Production, Engineering and Regulatory Affairs managers and coordinators working in the manufacture of sterile medical devices or devices produced in controlled environments
  • Professionals needing a sound foundation before specialising in sterilisation, cleanroom or sterile packaging validation
  • Consultants and Technical Managers involved in special process validation and audit preparation

Instructor

Leda Longhi

Exemplar Global-certified ISO 13485:2016 and MDSAP Lead Auditor, specialising in special process validation (EtO, radiation and steam sterilisation under ISO 11135, ISO 11137 and ISO 17665), with experience in ANVISA and LATAM regulatory dossiers, Quality Management and Medical Device Vigilance.