08-035-24-EN

Process Validation for Medical Devices

Präsenztraining​2 DaysBeginnerVirtuelles Klassenzimmer

Due to nature and complexity of medical devices, final inspection as the only production control will not be enough. Process validation offers an adequate toolbox to achieve safe design of manufacturing processes and to deliver evidence of their capability to manufacture medical devices within predetermined specifications. This seminar will deliver a clear understanding of the terminology used, solid regulatory knowledge and many practical examples for the planning, executing, reporting and maintenance of process validations in an efficient and sustainable manner. The contents of the seminar are based on international standards and regulations for medical devices including GHTF, ISO 13485:2016 and 21 CFR 820 (FDA). In addition, key elements of equipment qualification, statistical sampling plans, change control and the monitoring of validated processes are included using risk-based approaches.

This training is also offered in German, you can find the link here.

  • You will be qualified to carry out standard-compliant device qualifications and process validations for the manufacturing process of medical devices.
  • You will acquire know-how for an efficient validation process, both in your company and at your suppliers.
  • You will be familiar with the requirements and limitations for the application of risk-based process validation methods.

Day 1: Overview

  • Basic of process validation
  • Overview of the current regulation (ISO 13485, 21 CFR 820)
  • Terminology (IQ, OQ, PQ)
  • Validation planning
  • Risk-based sampling plans based on LTPD and AQL

Day 2: Workshop

  • Preparation of a concrete validation plan
  • Examples of IQ, OQ, PQ protocols and important conditions for implementation (documentation, measured values, traceability)
  • Integration of risk management according to ISO 14971
  • Summary and validation reports

Teilnahmebescheinigung der TÜV SÜD Akademie

People involved in the validation of manufacturing processes, such as:

  • QM specialists
  • Developer
  • Project Manager
  • Executives with responsibility in validation

This course addresses internationally valid standards and can also be held abroad.

Nettopreis (exkl. USt.)
ab1.299,00 €

Termin buchen
Seminar buchen: Process Validation for Medical Devices
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Ab 25.06.2024
Online
1.299,00 € exkl. USt.

Veranstaltungsnr.
9693

Dauer
​2 Days

Seminarplan anzeigen

Veranstaltungsort
Online

Preis

Nettopreis
1.299,00 €
20% USt.
259,80 €

Bruttopreis
1.558,80 €

Veranstaltungsnr.
9696

Dauer
​2 Days

Seminarplan anzeigen

Veranstaltungsort
Online

Preis

Nettopreis
1.299,00 €
20% USt.
259,80 €

Bruttopreis
1.558,80 €
Wie läuft eine Online-Prüfung ab?

 

Informationen zu den Anforderungen und dem Ablauf unserer Online-Prüfungen finden Sie hier.

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