Advancements in technology have forced companies to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and have higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such determinations.

We’ll also cover Computer-Off-the-Shelf (COTS) software, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services, indicating the benefits and risks of each model. We’ll discuss considerations for adopting software applications developed, tested, and supported using newer technical approaches, such as automated testing. In discussing these hardware and software options, we’ll include the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA’s current concerns and how to ensure your systems will meet their expectations.

Areas Covered

• GxP Systems
• FDA Trends in Compliance and Enforcement
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Waterfall and Agile
• Automated Testing
• Cloud Services
• Computer-Off-the-Shelf (COTS) Software
• Software-as-a-Service (SaaS)
• Infrastructure-as-a-Service (IaaS)
• Platform-as-a-Service (PaaS)
• Approach to Installation Qualification (IQ) for Cloud and SaaS systems
• Maintaining a Validated System
• Policies and Procedures related to validation
• Industry best practices
• Q&A
  

Who Should Attend

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Contract Research Organizations (CROs)
• Laboratory Testing Facilities for Clinical Samples
• Vendors and consultants working in the life sciences industry who are involved in computer system development, implementation, testing, validation, maintenance and compliance
  

Why Should You Attend    

The attendees will learn about the FDA’s approach to modernizing the Agency’s technology and how that will benefit both the Agency and the industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products. This approach is amenable to the agile software development methodology, which can be adapted for use in validation. We’ll discuss the pros and cons of each approach, and industry best practices for success.

We’ll discuss a variety of newer technologies and how they can be applied in an FDA-regulated environment with ease and assurance that systems will be compliant. Learn the key factors necessary to embrace newer technology and change and to guide the organization along this journey successfully.

Topic Background    

Many companies working in FDA-regulated industries have been in business for decades and rely on an aging technology infrastructure and applications to manage work. As technology evolves, it can be difficult to decide what innovations to embrace and, if so, when to do so. A technology roadmap is needed to understand the current state of infrastructure and applications and the future desired state. How will companies address the gaps, and what will it take to get there?

In this webinar, we’ll explore the ways in which each company can begin to implement newer technologies and validate them using simple, common-sense approaches. For example, by leveraging cloud services, a company can move the day-to-day management of IT operations, an increasingly difficult and time-consuming internal responsibility, to a cloud model, where the vendor takes on much of the responsibility. The company is still responsible for the compliant operation of systems and the integrity of data but can delegate the more mundane, time-consuming tasks to an external resource by ensuring appropriate oversight.