Process Validation for Medical Devices

Course Description

Ensuring quality by final inspections and tests alone is not sufficient due to complexity of medical devices. The instrument of process validation proves that manufacturing processes are developed safely and work reliably over the entire duration of the product life. Based on clear terminology and practical examples, the seminar gives you the necessary expertise to carry out and design a process validation. Thereby, relevant requirements from ISO 13485:2016, FDA CFR 21 Part 820 and the Medical Device Single Audit Program (MDSAP) will be used and explained. In addition, key elements of the statistical sampling plan design for validated processes are explained and integrated into the validation planning by means of a risk-based overall approach.

Course Contents

Day 1: Overview

• Basics of process validation
• Overview of the current standards: ISO 13485:2016 and FDA CFR 21 Part 820
• Terminology (IQ, OQ, PQ)
• Validation planning 
• Risk-based statistical sampling plans based on RQL and AQL
• Documentation
• Change Management

Day 2: Workshop

• Preparation of a validation plan based on an example from the field of non-active medical devices
• Examples of IQ- and OQ-protocols and important conditions for implementation (documentation, measurements, traceability)
• Integration of risk management according to ISO 14971
• Summary and validation reports

Who Should Attend

Employees and persons involved in the validation of manufacturing processes, such as:

• Quality management (QM) specialists
• Developers
• Project managers
• Executives with responsibility in validation
• Consultants
• Service provider for validations

Course Objectives

• You will be qualified to carry out standard-compliant validations for the manufacturing process of medical devices
• You will acquire know-how for an efficient validation process, also in relation to change management.
• You will know the conditions and limitations of applying risk-based validation methods.

Requirements

No requirements are necessary.

Methodology

This single training addresses internationally valid standards. The contents of the training correspond to the current status of the revision/harmonization.