Management Forum Logo

Presented by
Management Forum

Process Validation for Medical Devices Training Course

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

5-6 June 2024
+ 15-16 October 2024 »

from £1099

Need help?  Enrol or reserve


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.

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

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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

Enrol or reserve

The Process Validation for Medical Devices course will cover:

Why is Process Validaton Needed?

  • Regulatory need - USFDA, EU, UK
  • Quality need - 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 improvement in the selection of URS 

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

Instalation 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

Valdiation Protocol Execution

  • Recording of findings
  • Managing excursions from required performance
  • Data Integrity
  • Considerations
  • Approval

Change Control, Revalidation & Requalification

  • Risk-based change control
  • When to requalify, how to revalidate?

Group Exercise: Review of Exisiting Validation Plan & Report

  • Critique of format
  • Critique of content

Workshop: Validation Plan & Report

  • Breakout groups to review and suggest imporvement in Validation Protocol

Enrol or reserve

Mustafa Edik

Mustafa Edik is an 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.

While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.


More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5-6 June 2024

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 14207

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 01 May

View basket 

Not ready to book yet?

for 7 days, no obligation

15-16 October 2024

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 14208

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 10 Sep

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.


  • Surgical Fusion Technlogies GmbH

United Kingdom

  • Kindeva Drug Delivery

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749