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
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
7-8 February 2024
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
Until 03 Jan
5-6 June 2024
08:30-16:45 UK (London)
Course code 14207
Until 01 May
15-16 October 2024
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
Until 10 Sep
* 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: