TSY In House Training #905: Understanding The ISO 13485:2016 & Regulatory-Compliant Process Validation

Sep 29

2 min read

TSY In House Training #905: Understanding The ISO 13485:2016 & Regulatory-Compliant Process Validation — Training Ongoing.

Process Validation is a systematic, documented approach used to confirm that a manufacturing process can con-sistently produce outputs that meet predefined quality specifications. It is especially critical in highly regulated in-dustries such as medical devices, pharmaceuticals, and biotechnology, where final product inspection alone is not enough to ensure safety, quality, or performance. Instead of detecting defects at the end, process validation en-sures that the entire process is capable and under control, so quality is built in from the beginning.

e goal of process validation is to generate objective evidence that, under established and controlled conditions, the process will repeatedly deliver products that conform to specifications. This evidence is collected through planned activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—each stage confirming different aspects of process capability and stability.

Ultimately, process validation supports regulatory compliance, enhances product reliability, and protects patient safety by eliminating the reliance on end-product testing alone. It ensures that quality is designed and maintained throughout the manufacturing lifecycle, making it a foundational component of an effective quality management system. Properly executed, process validation leads to reduced defects, fewer recalls, and stronger confidence from regulators and customers alike.

This training course may be used in its original presentation format or it may be customised by referring to the de-gree of business nature.

Date: 26th & 27th August 2026

Venue: NationGate Solution (M) Sdn. Bhd., Prai, Penang

Course Objectives:

This two-day intensive training provides participants with a structured, lifecycle-based understanding of process validation—from planning through execution and into ongoing maintenance based on ISO 13485:2016 and GHTF.SG3.N99. Here are the learning objectives for the two days training program; after completing this program, participants will be able to:

Understand the regulatory and ISO 13485:2016 requirements for process validation in medical device manufacturing.
Differentiate between verification and validation and identify when validation is required based on risk and product complexity.
Develop and execute a robust validation lifecycle, including IQ, OQ, and PQ phases, aligned with industry best practices.
Interpret validation protocols and results to make informed decisions about process capability, reproducibility, and compliance.
Implement effective change control and revalidation strategies to maintain validated states and ensure product quality.

Who Should Attend:

QA Managers, Production & Operations Managers, Manufacturing & Process Engineers, Quality Engineers & Regulatory Affairs Personnel or anyone who are seeking to strengthen process validation strategies.

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