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Medical Devices Process Validation Training Course: QMS Integration, Risk Assessment and URS Development Through IQ, OQ and PQ Execution (June 4th - June 5th, 2026)

Research and Markets

Wed, February 25, 2026 at 7:26 PM GMT+9 4 min read

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Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants a competitive edge, ensuring product consistency and providing significant business benefits through efficient documentation and practical insights.

Dublin, Feb. 25, 2026 (GLOBE NEWSWIRE) – The “Process Validation for Medical Devices Training Course (June 4th - June 5th, 2026)” training has been added to ** ResearchAndMarkets.com’s** offering.

This course has been designed to focus on process validation for medical devices.

Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently producing a finished product of the required quality.

Day one will review the Regulatory and Quality Management System (QMS) links to process validation - essentially the need for validation. It will look at the preparation steps to be taken, including initial Risk Assessment, User Requirement Specifications (URS), the format of URS and include a practical review of bad versus good examples.

Day two of the course reviews the Installation Qualification, Operation Qualification and Performance Qualification process (IQ, OQ and PQ) reviewing how this fits with regulatory needs and technical documentation. It will also look at the validation master plan and discuss continuous PQ and when that may be appropriate. Additionally, validation protocol content and execution, covering the recording of findings, managing excursions from required performance, plus other considerations will be reviewed.

Data integrity with an overview of the GAMPv (Good Automated Manufacturing Process) for software will also be included.

This is an excellent opportunity to receive a practical approach to Process Validation for Medical Devices.

Benefits of Attending

**Gain **a clear understanding of how Process Validation fits into the Quality Management System

**Understand **the regulatory drivers for Process Validation

**Know **the scope of FDA, EU and UK guidelines

**Realise **significant business benefits by clarifying the key purposes of validation

**Receive** a practical demonstration of document format and content expectations

Who Should Attend:

Validation specialists new to the medical device industry

Quality and Regulatory specialists wanting to understand where Process Validation fits into compliance needs

Process engineers

Validation and Qualification managers

Operations managers

 






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Key Topics Covered:

Day 1

Why is Process Validation Needed?

Regulatory need - USFDA, EU, UK

Quality needs - fitting into the QMS

Links for Design and Development

Validation Policy, Validation Master Plan, Validation SOP

Process Mapping Study

Where to Start?

Risk assessment

Direct, Indirect, or no impact to product quality

Level of validation required

User Requirement Specification (URS)

Review internal procedure.

Format

Approval

Critical Process Parameters

Critical Quality Attributes

Group Exercise - Review of an Existing URS

Critique of format

Critique of content

Workshop: URS

Breakout groups to review and suggest improvements in the selection of URS

Day 2

Factory Acceptance Test

Definition and example

Site Acceptance Test

Facility Qualification

HVAC

Water

Steam

Compressed Gas

Computerized System Validation

Electronic Signatures and Electronic Records

IT Cyber Security

Disaster Recovery & Business Continuity

GAMP5

Cleaning Validation

Prerequisites and example

Personnel Qualification

Training

Education

Analytical Method Validation

Prerequisites and example

Supplier Assessment

Supplier Audit & Qualification

Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

Regulatory need? How will this fit with Technical documentation?

Risk-based commissioning and qualification

Quality Need? What drives this from the QMS?

Links for Design and Development

Validation Master Plan

Continuous PQ - What and when?

Validation Protocols

Review internal procedure

Example of good practice with links to conformity assessment requirements

Sampling plan requirements

Validation Protocol Execution

Recording of findings

Managing excursions from the required performance

Data Integrity

Considerations

Approval

Change Control, Revalidation & Requalification

Risk-based change control

When to requalify, how to revalidate?

Group Exercise: Review of Existing Validation Plan & Report

Critique of format

Critique of content

Workshop: Validation Plan & Report

Breakout groups to review and suggest improvements in the Validation Protocol

Certifications:

CPD: 12 hours for your records

Certificate of completion

Speakers:

Mustafa Edik
Independent GMP Consultant and Auditor

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

For more information about this training visit

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