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.

4.35 (1831 reviews)

Udemy

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English

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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

Course Gallery

Medical Device Process Validation. ISO 13485. IQ OQ PQ. – Screenshot 1 — Screenshot 1 – Medical Device Process Validation. ISO 13485. IQ OQ PQ.

Medical Device Process Validation. ISO 13485. IQ OQ PQ. – Screenshot 2 — Screenshot 2 – Medical Device Process Validation. ISO 13485. IQ OQ PQ.

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Medical Device Process Validation. ISO 13485. IQ OQ PQ. – Screenshot 4 — Screenshot 4 – Medical Device Process Validation. ISO 13485. IQ OQ PQ.

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Our Verdict

This course offers extensive knowledge on process validation and related regulations, making it a valuable resource for professionals in medical device or pharmaceutical industries looking to improve their understanding. However, potential learners should be prepared for occasional quiz phrasing issues and recognize that certain topics might not receive the depth of treatment they expected.

What We Liked

Comprehensive coverage of process validation, IQ, OQ, PQ, and industry-specific regulations like ISO 13485 andCode of Federal Regulation (21 CFR section 820)
Well-structured course with clear objectives, presentation of topics, quiz items, and summary for each lesson
Complements technical information with practical examples, making complex concepts more accessible
Includes a wide array of resources, such as the Validation Master Plan and Design of Experiments
Caters to beginners and professionals alike from life science industries, including medical devices and pharmaceuticals

Potential Drawbacks

Quiz questions have been reported to be inconsistent in their phrasing and may cause confusion for some learners
Lacks depth in certain areas like real-world examples, risk management, process capability indices (CP & CPK), and test method validation topics
ISO 13485:2016 standard is not referenced directly, as the course relies on an older version for specific clauses
Presentation style has been described as monotonous by a few learners