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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.

7-8 February 2024
+ 5-6 June 2024, 15-16 October 2024
from £1099

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Overview

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 (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.

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:

Welcome and Introduction

  • Objectives for the day
  • What do you want from the day? 

Why is Process Validaton Needed?

  • Regulatory need - USFDA, EU, UK
  • Quality need - fitting into the QMS
  • Links for Design and Development
  • Validation Master Plan

Where to Start?

  • Risk assessment
  • Direct, Indirect, or no impact to product quality
  • Level of validation required

Usere Requirement Specification (URS) - The Good, the Bad and the Ugly

  • Review internal procedure
  • Format
  • Considerations - SMART
  • Approval

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 

Feedback from Workshop

Wrap up of Day

  • Summary 
  • Preview of day two (homework)
  • Q & A / Discussion

 

Review of Day One

  • Overview of lessons learned
  • Objectives for day two

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

  • Regulatory need? How will this fit with Technical documentation?
  • 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

Group Exercise: Review of Exisiting Validation Protocol

  • Critique of format
  • Critique of content

GAMP v

Wrap up of Course

  • Summary and key take aways
  • Q & A / Discussion

Enrol or reserve

Stuart Angell
Ivdeology

Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.

More details

Book Process Validation for Medical Devices Live online/Classroom training

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

7-8 February 2024

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 14206

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

Until 03 Jan

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Not ready to book yet?

for 7 days, no obligation

5-6 June 2024

Classroom
Rembrandt Hotel
London

08:30-16:45 UK (London)
Course code 14207

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 01 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

 
Not ready to book yet?

for 7 days, no obligation

15-16 October 2024

Live online

09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 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.

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

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy