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

(MENAFN- GlobeNewsWire - Nasdaq) 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'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

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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