Computer Software Assurance
Is CSA the future for validation?
This will be an interactive webinar.
- What is CSA?
- What's the difference with GAMP practice?
- How can I use it in my business?
Are these also your questions.....this webinair will give you some guidence.
For this session we ask all participants to create a (free) account on https://miro.com/login/
|Event Date||30-Mar-2021 15.00|
Welcome & Introduction
Marcel Schakel, Chair ISPE GAMP Benelux COP
What is CSA?
Sion Wyn Update/last from regulators? ISPE and CSA?
Risk based testing
Frans Boeijen During this Webinar we want to have a closer look at how CSA can affect Validation Testing. The most important aspect of CSA is Critical Thinking to drive measures, including verification and documentation. Can we apply Critical Thinking to make Testing more efficient while maintaining effectiveness? GAMP®5 states in appendix D5: “Testing should be carried out in accordance with an appropriate test strategy based on the risk, complexity, and novelty of the system.”
Frans Boeijen During an interactive workshop we want to explore together with all participants the possibilities, risks, advantages and disadvantages of applying Critical Thinking to Risk Based Testing And Verification. Frans will propose a possible setup of this and all participants get the possibility to give input on a big virtual whiteboard. We will use the website Miro for this interactive session. For this session we ask all participants to create a (free) account on https://miro.com/login/
Last Discussions / summary
ISPE / Conformity Limited
Sion Wyn is a well-known and internationally acknowledged specialist in computer systems validation and compliance, and an active member in ISPE Global/Europe GAMP community
Frans Boeijen is an independent trainer/consultant in computer systems validation and data integrity compliance, and an active member in GAMP COP Benelux community.
pi life sciences
Bart Degroote is a seasoned compliance expert with broad experience in GMP processes and a Computer System Validation specialization.