Overview:
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We'll cover the latest draft guidance from FDA on Computer Software Assurance (CSA), a risk-based approach using critical thinking as a driving factor for validation.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 you should 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:
- Learn how to identify "GxP" Systems
- Discuss the Computer System Validation (CSV) approach based on FDA requirements
- Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
- Learn the differences introduced by ISPE in the current GAMP®5, 2nd Edition, issued in July 2022
- Learn about cloud service and SaaS providers and the best approach for conducting a vendor audit and performing Installation Qualification (IQ) for validation
- Learn about the System Development Life Cycle (SDLC) approach to software development, testing, and release, including the application of automated testing to streamline activities, particularly for updates
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
- Understand how to maintain a system in a validated state through the system's entire life cycle
- Learn how to assure the integrity of data that supports GxP work
- Discuss the importance of "GxP" documentation that complies with FDA requirements
- Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
- Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures and data integrity requirements, both of which are somewhat intertwined
- Know the regulatory influences that lead to FDA's current thinking at any given time
- Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
- Understand the need to include an assessment of a computer system's size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
- Learn how to best prepare for an FDA inspection or audit of a GxP computer system
- Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
- Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
- Q&A
Who Will Benefit:
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- IT Security Staff
- QC/QA Managers and Analysts
- Production Managers and Supervisors
- Supply Chain Managers and Supervisors
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP, GLP, GCP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
- College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements