Validation in an Agile environment
The GAMP guidance describe validation and software development in a risk-based waterfall approach, as well as agile approach reading latest new published GAMP GPG Enabling Innovation. Examples of an Agile approach are management by Scrum and Extreme Programming (XP). This webinar will explain the basic principles of Agile development and will give examples of a validation approach in an Agile development environment.
Our speakers are:
- Jan Kraneis, Scrum Master, Arvato Systems
- René van Opstal, ISPE Benelux GAMP COP
- Bernard Siebens, Deloitte Belgium & Pieter Tombeur, Terumo Europe
Attending the webinar is free for ISPE members. Non-members have to pay a fee of only €10. Registration is required.
Please chack your spam folder when your do not receive a confirmation mail after registration.
Event Properties
| Event Date | 30-Mar-2022 15.30 |
| Event End Date | 30-Mar-2022 17.00 |
| Capacity | 100 |
| Registered | 82 |
| Individual Price | €10.00 |
Agendas
| 15:30 |
Welcome & Introduction - Marcel Schakel (GAMP COP) |
| 15:35 |
Introduction to Agile - Jan Kraneis (Arvato Systems)Agile methodologies change the project management of software development projects to an iterative approach - to comply to quick changing requirements and markets, and reducing risk in the developments process. This is achieved by reducing the design phase to a minimum, creating executable software, and coordinating with the customer as early as possible. The change of core values in the development process requires a mindset change for all involved parties and leads to more transparency, better communication and higher quality. In this session, the basic principles of agile development methodologies are covered. |
| 15:55 |
Agile & Validation by ISPE GPG - René van OpstalISPE launched a GAMP Good Practice Guide Enabling Innovation. The presentation will give an overview of the subject Adopting Agile Software Development in a GxP environment as described in the Guide.. |
| 16:15 |
Agile validation case - Pieter Tombeur (Terumo) & Bernard Siebens (Deloitte)Pieter Tombeur, Compliance & Validation Manager at Terumo will be joining Bernard to talk about the way in which Agile Validation meets computer system validation requirements and aligns with the best practices and will share some success stories and importance of tailoring the Agile Validation strategy |
| 16:35 |
Q & A session |
| 17:00 |
Closure |
Speakers
Jan Kraneis
Scrum master, Arvato Systems
Jan Kraneis is certified Scrum Master and Agile Coach at Arvato Systems. He has more than 15 years of experience in initiating and leading agile transformations in different industries.
René van Opstal
Consultant - van Opstal Consulting
René is an experienced and intelligent consultant in the field of process automation and Computer system validation. As an active member of ISPE René founded the GAMP Benelux COP and is board member of the ISPE Netherlands affiliate.
Bernard Siebens
senior manager - Deloitte Belgium
Bernard is a senior manager within Risk Advisory at Deloitte with focus on Life Science industry. He has 8+ years of experience in the industry in different roles covering process validation, change management, quality management, regulatory compliance, computer system validation and IT Data Integrity. His current focus includes leading global transformation projects from existing ERP platforms to SAP S/4 HANA. Bernard is also a board member of the Belgium Affiliate of the International Society of Pharmaceutical Engineering (ISPE).
Pieter Tombeur
ICT Manager Compliance & Validation, Terumo Europe
With more than 13 years of experience in Life Science Industry, Pieter has expertise in a broad range of IT Compliance topics like CSV, GDPR, J-Sox and Data Integrity. His expertise lies with IT Business applications, test management, eQMS systems and SAP platforms. His current role is to guide the Terumo Europe IT team to meet compliance standards during projects and day to day operations and to govern the ICT quality processes.”