Special Process Validation for Medical Devices (Sterilisation, Cleanrooms and Packaging under QMSR, MDR and RDC 751)

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01

Course description

An integrated course on validating special processes in medical device manufacturing (sterilisation, controlled environments/cleanrooms and sterile barrier systems), connecting ISO 13485:2016 (Clause 7.5.6), FDA QMSR, MDR 745/2017 and RDC 751/2022 requirements in a single, consistent view of compliance.

02

Course objective

Equip participants to plan and defend a unified special process validation programme, ensuring traceability between risk, specifications, testing and continuous monitoring, with acceptance in ANVISA, FDA and European notified body audits.

03

Course programme

40h of in-depth learning
  1. 01

    The special process concept (ISO 13485 Clause 7.5.6)

  2. 02

    A risk-based approach (ISO 14971) applied to validation

  3. 03

    Integration of sterilisation, cleanrooms and sterile packaging

  4. 04

    FDA QMSR and MDR 745/2017 expectations

  5. 05

    RDC 751/2022 and Good Manufacturing Practice requirements

  6. 06

    Revalidation and continuous monitoring strategy

  7. 07

    Documentation, traceability matrix and the validation dossier

04

Who can attend?

  • Quality, Validation, Production, Engineering and Regulatory Affairs managers and coordinators, and consultants working in the manufacture of sterile medical devices or devices produced in controlled environments.