ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP∗ computerized system compliance and validation for companies and suppliers within Life Science industry.
As of August 2022, a second edition of the GAMP 5 has been released, the first review since the first edition from 2008 and guess what- it emphasizes the need of incorporating modern software tools and automation to achieve greater control and higher quality. Imagine the opportunities!
Many procedural areas of the computerized lifecycle as well as terminology and concepts are affected in the new revision. Just to name a few, where changes are added:
- Agile development, involvement of Continuous Integration & Delivery (CI/CD) and usage of software tools
- Artifical Intelligence and Machine Learning
- IT infrastructure
- Critical Thinking
- Significant changes to documentation and Electronic Production Records
Automation, development and modern technologies have been the areas of expertise at Lemontree for many years and now we are thrilled to launch a full training day dedicated to our colleagues within the Life Science Industry. This is an exciting opportunity for the industry to further improve their business by using technology and tools adapted for a modern world.
During the day, we will also host a session for people who are familiar with the basics of GAMP, but also are interested in Test Automation, CI/CD and practical usage of software tools for Life Science.
The GAMP training will be in English.
After this training you will understand the basics of GAMP 5 and how it is applied within the regulated industry. You will know how to navigate through the GAMP5 and understand terminology used. You will gain information on updates in the Second Edition of GAMP5. You will acquire knowledge about testautomation and understand the benefits and how-to.
People attending the parallell track about automation will be given practical knowledge about how automation can be achieved complying with Life Science regulations.
Who should attend
QA and QC specialists, Validation Specialists, Process Engineers, Managers and Process owners who need fundamental understanding of computerized system compliance and regulations and/or need knowledge about automation in LifeScience.
Management who would benefit of updating their GAMP5 knowledge and learn about modern technology applicable to their Businesses.
Consultants working within the regulated industry.
08:30 Welcome and Introductions
Regulatory environment and risk-based approaches
FDA CDRH Case for Quality overview
GAMP 5 Second Edition
Background, drivers, and objectives
Life Cycle Approach
Specification and Verification
Tools and Automation
Quality Risk Management
New and Expanded material
CSA (Computer Software Assurance)
Wrap-up, conclusions, outstanding questions
Sion Wyn will walk us through the guideline on a higher level. Key concepts, methods and processes are presented to give the audience a good understanding of how GAMP is structured and used in the regulated industry.
We will present requirements-, design-, traceability- and testing concepts as well as terminology used in the Guide. Quality and risk management of computerized systems will also be a topic to discuss. Q & A.
Part of day: Ludwig Östlund will teach us about test automation, its benefits and how it can be implemented within regulated industry. He will present best practices about what should be automated and how to introduce test automation to your organization and how to make it over time, as well as success stories for test automation projects that has been deployed by life science companies. Q&A
Date: Tuesday 17th January 2023
Place: Magasinet, Sveavägen 53
Price: 6500 SEK.
About the speakers
Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field.
He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11 and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11.
Sion Wyn is the editor of ISPE’s GAMP5 Guide – A Risk-Based Approach to Compliant GxP Computerized Systems, co-lead of the ISPE GAMP Guide – Record and Data Integrity, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee.
Sion Wyn received the 2006 ISPE Professional Achievement Award, which honors an ISPE Member who has made a significant contribution to the pharmaceutical industry. He received the ISPE UK Fellow Award in 2016.
Test Automation expert, Lemontree AB. Ludwig has many years of experience in roles such as delivery manager, test strategist and technical project manager. He has been lead engineer in many automation projects that have been rolled out in different companies within all kind of industries, including Life Science. He has also worked in implementing Continous concepts in development oriented companies.
In addition, Ludwig is also the manager of the TestOps Team at Lemontree where different testing methodologies and technologies are the main areas of expertise.
Välkomna att göra anmälan!
Vid fler anmälda från samma bolag erhålles rabatt om 10 %
Vid frågor kontakta Lemontrees konsultchef Life Science Paula Diago
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Telefon: +46 790 980 802