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.
4.39 (1798 reviews)
6,153
students
2.5 hours
content
Mar 2023
last update
$79.99
regular price
What you will 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
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2742672
udemy ID
1/6/2020
course created date
11/5/2020
course indexed date
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