Process Validation for Medical Devices

Produktnummer 08-035-24-EN

Training Präsenz / Virtuell
2 Days
Beginner

Details

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.

Vorteile | Advantages

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.

Inhalte | Content

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

Abschluss | Degree

Teilnahmebescheinigung der TÜV SÜD Akademie

Zielgruppe | Target group

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

QM specialists
Developer
Project Manager
Executives with responsibility in validation

Hinweis | Note

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

Duchführende Akademie | Executing Academy

Alle Online Termine dieser Veranstaltung werden von der TÜV SÜD Akademie GmbH in Deutschland durchgeführt. Bei Onlinetrainings gelten daher zusätzlich die Allgemeinen Geschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehen wir Ihnen gerne unter [email protected] zur Verfügung.

1.389,00 €Nettopreis

1.666,80 €Bruttopreis

Preisdetails einblenden

Nettopreis1.389,00 €

20% USt.*277,80 €

Bruttopreis1.666,80 €

*Kann außerhalb von Österreich abweichen

Aktuell sind keine Veranstaltungen buchbar.

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Wie können wir helfen?

+43 5 0528 3030

[email protected]