GAMP5 and data integrity: Trends for manufacturing systems

10:00 - 11:00 (60 min)

Hilary Mills-Baker

Hilary is the European Quality and Validation Manager for Emerson Automation Solutions where she oversees all Life Science projects being supplied with Syncade or DeltaV from a Quality and Validation stance. She is a member of the ISPE Special Interest Group for Process Control Systems, and co-lead the update of the PCS guide following the publication of GAMP5. She now delivers the training on this topic for ISPE with Karen Ashworth. She has recently been involved in the team writing the guidance for Practical Approaches to Data Integrity for Manufacturing Systems, which was published in 2019. She is the co-chair of the GAMP steering chair. In her spare time, Hilary is learning silversmithing.

Karen Ashworth

Karen is a validation consultant at Karen Ashworth Consulting Ltd. where she specialises in the validation of process control systems, working mostly with suppliers to the life sciences industry. Karen has over thirty years of experience in process automation including roles as system owner, production manager, control system supplier, quality systems internal auditor and consultant. During this time, she has worked in a wide range of industries including nuclear, metal heat treatment and fine chemicals as well as life sciences and has managed projects from small environmental monitoring systems up to multi-million pound control systems.

Karen is a member of the UK GAMP COP Steering Committee. She was part of the editorial team for the GAMP Good Practice Guides ‘Testing of GxP Critical Systems’ and ‘A Risk Based Approach to Process Control Systems’ and she co-led the international team who updated the testing good practice guide. She was also lead author on the Good Practice Guide ‘Data Integrity – Manufacturing Records’, She delivers the ISPE Risk Based Validation of Process Control Systems training course with Hilary Mills-Baker.  When not at work, you’ll probably find Karen chairing the governors at a local primary school, coaching orienteering to a group of 6-11 year-olds who can all outrun her or trying hard to march neatly and play a sousaphone at the same time.

Hear how data integrity considerations can be integrated when validating manufacturing systems. We'll be joined by expert ISPE training providers who will share examples, tips and best practices.

Hot buffet lunch in restaurant

13:00 - 14:00 (60 min) 

GAMP 5 CSV and the future of validated systems to support innovation

14:00 -14:45 (45 min) 

Liam Pollard, CSV Service Implementation Manager at Qualsys

Liam leads the EQMS implementations which require computerised system validation. Since joining Qualsys, Liam has delivered over 20 implementations. 

Liam will share how he has helped life science, clinical and medical device companies to validate their quality management system. He'll share how and why his approach has shifted from IQ, OQ, and PQ to GAMP5, and give you time to discuss with colleagues. 

How to engage leadership, contractors and the wider business with your quality and compliance requirements

11:15 - 12:15 (60 min)

Kate Armitage, Compliance Director at Qualsys 

Kate’s all about improvement, at work and at home. After several years managing quality systems in the healthcare world, Kate brought her keen analytical mind to Qualsys, where she oversees our ISO compliance and the development cycle of our software. When she’s not making Qualsys fitter, faster and stronger, she’s knee-deep in Peak District mud training for her next 10k. 

Kate is part of BSI ISO Committees and is MCQ CQP. Armitage is best known for her culture of quality training course which she has delivered to hundreds of quality practitioners across the globe. 

Challenges of SaaS solutions for GAMP

14:45 - 15:15

Graham Parker is part of the GAMP Special Interest Group on Cloud Computing which is currently focusing on the challenges of SaaS solutions. Graham will be sharing his experiences and discussion points. 

Graham Parker

Case study 

Meeting CFR Part 11 

12:15 - 13:00 (45 min) 

Kaye Eames, Training Manager at Qualsys 

Kaye’s role at Qualsys involves training our customers at all stages of their journey with our quality management software. Kaye's passion is data integrity. 

FDA 21 CFR Part 11 and EU Annex 11 set out a list of requirements for electronic signatures and records. However, they don't tell you how to apply the requirements. With a quiz, examples and tips, you'll have a clearer idea about what best practice looks like. 

Optional: How quality management software technology is used by life science companies 

15:15 - 16:00 (45 min)

Michael Ord, Director at Qualsys

Guided, interactive demonstration 

How can technology help you to automate processes without creating a validation headache? How have other life science companies implemented EQMS? This session will give you an overview of how you can manage everything from documents to training records, ethics policies to controlling risk assessments, data integrity to compliance, audits to suppliers - in a single system. 

If you would like to join a list of people who are notified in case of cancellations, please email 

Emily Hill: emily.hill@qualsys.co.uk

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