Computer System Validation Courses
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*attending at least 5 of the 6 courses.
More than 25 years of experience in the life science sector and still passionate about CSV. Passing on knowledge is my passion. Together with Jonathan Boel, M. Carme Montull, Thierry Provinciael and Pieter Smits will walk you through very interesting topics. Do not miss it!
SAP 4 Hana and other ERP systems Supplier Qualification
- The Supplier Assessment is a key document in the validation of a computerized system, and even more so if it is a Cloud system.
- We will discuss how to address the SLA for an ER system and the differences when it comes to the analysis of a supplier of a system widely used in the pharmaceutical sector such as SAP.
SaaS Validation & IaaS Qualification
Validation process of IaaS (Infrastructure as a Service), PaaS (Platform as a Service) and SaaS (System as a Service)
- Applicable regulations
- Main differences between the validation of an On Premise system and a Cloud system.
- Key points to be considered.
Computer System Assurance (CSA)
- Focus on what really matters – Quality
- Critical thinking for computer systems.
- Use of automated tools.
- Pragmatic approach to compliance.
Artificial Intelligence Validation Consideration - AI / ML *
- Regulatory Framework AI / ML for Software as Medical Devices.
- Software as Medical Devices as AI / ML action plan.
- Possible Validation Model for AI / ML
* AI = Artificial Intelligence / ML = Machine Learning
FDA 21CFR Part 11 – Two Factor Authentication
- Requirements and mapping on how to authenticate according to FDA 21 CFR part 11.
- Impact of Two Factor Authentication on FDA 21 CFR part 11.
Software as Medical device
- Developing SAMD according to applicable Standards (ISO13485, ISO14971, EN62304…)
- Implementing according to good SDLC, engineering, and quality practices
- Pitfalls to avoid
We can help your company implement CSA
QbD Group has experience in the implementation of CSA (Computer System Assurance) as computer system assurance. We have validated artificial intelligence solutions, SaaS systems, vendor qualification strategies applying Computer System Assurance or CSA.
QbD is an expert in IT systems validation
We make it easy for you, the QbD Group incorporates the industry’s best compliance practices in the validation of IT systems supporting a multitude of companies in:
- User Requirements
- Validation Plan
- Risk Assessment
- Technical Documents (Functional Specification (FS) / Design Specification (DS))
- Traceability Matrix
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Final Validation Report