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We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately and data integrity requirements.
We'll cover the latest draft guidance from FDA on Computer Software Assurance (CSA), a risk-based approach using critical thinking as a driving factor for validation. We'll talk about the newest GAMP®5, 2nd Edition and how it aligns with CSA.
We'll also cover the thoughts from GAMP®5 and CSA for moving toward non-linear forms of software development, including agile, artificial intelligence (AI), machine learning (ML), and others.
We will cover the approach for validating/qualifying all components of FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors, and we'll provide the roadmap.
We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work.
Why should you Attend:
A critical element of any computer system implementation project is the infrastructure that supports it. This varies, including hardware and software, and must be a foundation that's qualified and able to support a system in a validated state.
In this webinar, we'll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions. There are specific things to watch out for to ensure you are properly supported and covered, including security, access control, incident reporting, change control, and maintenance of the system. Learning the best approach for different types of hardware and software will help you simplify your work. Rather than always doing things the way they've been done for decades, we'll provide some thoughts and suggestions about how to leverage technology and the vendor's work to make sure you're doing things efficiently and effectively without risking quality or compliance.
Areas Covered in the Session:
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