Process Validation for Medical Devices

• 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.

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.