Shortcut: CSA - Computer Software Assurance
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Target Group
Objectives
The result is that these companies either do not take a risk-based approach at all or, more often, despite taking a risk-based approach, still focus primarily on extensive validation documentation rather than on risk to the patient or product quality, as well as the software quality itself.
A group of life science industry representatives has teamed up with the FDA to launch an initiative to promote a risk-based approach that focuses more on software quality while significantly reduces the documentation burden. The result is what is called Computer Software Assurance (CSA), for which the FDA will publish a related guidance document (Guidance for Industry).
In this shortcut, you will learn first-hand what CSA is all about from one of the founders of the so-called FDA-Industry CSA Team (FICSA), which created CSA and produced the associated guidance document. You will learn how to integrate CSA ideas into existing validation processes, why you should do so, and what benefits you can expect.
Programme
- What is CSA all about, what are the differences to CSV?
- What is the added value of CSA?
- Is CSA compliant with all laws and regulations?
- What can be done to consider CSA in software validation?
- CSA Introduction:
- Key aspects of CSA
- CSA vs. CSV (comparison with existing software validation guidelines and best practices such as GAMP 5).
- How to consider CSA when validating software:
- Effectively address the risk-based approach
- Reduce the burden of validation documentation
- Use of alternative test documentation methods
- Use of software QA activities that have already been performed prior to validation (keyword: vendor testing)
- Beispiele:
- A common document for user requirements, risk and test management, and traceability
- Different types of test documentation
- Real project benefits
Further Information
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de
Questions regarding Organisation:
Mr Maximilian Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Costs
| Regular Fee*: | € 399,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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