Medical Device Process Validation. ISO 13485. IQ OQ PQ.

Validate a process to gain approval to sell medical devices in the EU, U.S. & Internationally. Compliance to ISO 13485.

Created by: Martin Conneely
Academic

What Will I Learn?

• Understand what Process Validation means for any industry.
• The course will focus on validation for the life science industry especially the medical device industry.
• Understand why we need process validation.
• Understand when we need to validate.
• Process validation within the medical device industry. Covers ISO 13485, Code of federal regulation (21 CFR section 820), quality system regulation (QSR)
• Understand the three types of validation. Prospective validation, Concurrent validation and Retrospective validation.
• Learn what user requirement specification (URS) means.
• Learn what design qualification means.
• Learn what Installation qualification (IQ) means which contains the Factory Acceptance Test (FAT) and the Site Acceptance Test (SAT)
• Learn what an Operational qualification (OQ) is. We will demonstrate an operational qualification.
• Learn how to demonstrate an Operational qualification (OQ)
• Learn what a performance qualification (PQ) is.
• Understand the process capability ratio and the process capability index. How it relates to process validation.
• Understand the process model, control limits and action limits. How it relates to process validation.
• Understand the Design of experiments and how this is used in the operational qualification part of process validation.
• Understand how risk management fits into the validation process.
• Understand how the ISO standard 14971 is utilised and therefore how risk management is applied.
• Docs: Validation Master Plan, Validation Plan, Validation Change control, Calibration, Process Validation, Preventive Maintenance, Validation Summary Report.
• Learn how regulation developed for the life science industry in the U.S. Learn how the regulation developed to include process validation

Requirements

• An understanding of a normal distribution.

Target audience

• Production Managers.
• Supervisors.
• Technicans.
• Manufacturing Engineers.
• Process Engineers.
• Quality Engineers.
• Research and Development Engineers.
• Process and Development Engineers.
• Professionals engaged in ISO 9001, ISO 13485, QSR, 21 CFR 820, Six Sigma and Quality Control.
• Regulatory Affair professionals
• Quality Assurance and Quality Control Professionals.
• Students who want to understand about the validation process.
• Entrepreneurs who want to develop new products in any industry but especially in the Medical device industry
• Small start companies who want to develop new products in any industry but especially in the Medical device industry
• This course will benefit any industry that needs to understand process validation.