FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

Advancements in technology have challenged traditional business models, increasing complexity and customer expectations. To meet these demands, organizations must adapt their work practices and tools. The webinar will compare agile and waterfall methodologies for software development and explore options like COTS, SaaS, IaaS, PaaS, and cloud services, addressing their benefits, risks, and FDA compliance requirements (e.g., 21 CFR Part 11, data integrity).

Questions arise, such as:

• “How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”
• “How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”
• “What about change control?”
• “How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures?”
• “Won’t our validation documentation be lacking?”

Why You Should Attend

We’ll 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. You’ll learn how to select an optimal solution and ensure that whatever that might be, you can build a contract and Service Level Agreement (SLA) that best suits your environment and needs.

We’ll also provide new approaches for meeting 21 CFR Part 11, FDA’s guidance for electronic records & electronic signatures, and also data integrity requirements, based on the “ALCOA+” principles: Attributable, Legible, Contemporaneous, Original or “True” Copy, Accurate, Complete, Consistent, Enduring, & Available.

Areas Covered

• Learn about Computer Software Assurance (CSA), the draft guidance from FDA in September 2022
• Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
• Learn about cloud services and cloud service providers to optimize your experience
• Learn ways to validate in the cloud without compromising quality or compliance
• Learn the pros and cons of an agile vs. waterfall approach
• We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
• Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
• Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but in the cloud
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach
• Learn how to comply with FDA’s 21 CFR Part 11 guidance for electronic records/signatures
• Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
• 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
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• 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 Should Attend

• Legal
• Marketing
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection.

Speaker(s)

Carolyn Troiano

Carolyn Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.

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