How to use ChatGPT & AI for Project Management to Improve FDA Compliance for Computer Systems & Data

The guidance on validation has been modified with the FDA's proposed draft guidance for Computer Software Assurance (CSA) in September 2022.

Addressing the approach to software development, testing and release this includes Agency support for use of agile as an SDLC methodology, along with other non-linear approaches. It also opens the door to consider use of Artificial Intelligence (AI), Machine Learning (ML) and a host of other technologies in FDA-regulated systems. The intent is to avoid creating a huge regulatory compliance cost to industry that has prevented companies from embracing these innovations.

Along with CSA, GAMP®5, 2nd Edition was published in July 2022 and aligns well with the proposed draft from FDA. Both focus on critical thinking and following a risk-based approach to testing. Both are intended to improve efficiency and effectiveness of validation work.

This session will provide some insight into current trends in compliance and enforcement. Those based on technology changes will continue to have an impact as new innovations come into use in the industry.

Regardless of the technology you intend to validate or the scope of the project, functionality to be delivered and resources and time to manage, a project management framework is very well suited for this purpose. It will allow you to know when scope, time, resources or deliverables are off track and need to be reined in. Project management gives insight into how time is being spent, what skills are needed for what activities and tasks, whether your budget is sufficient, and any risks or decisions that must be managed to ensure success.

There are many tools for planning, executing and reporting on project management, but you do not need to get sophisticated here. A simple Excel or other type of spreadsheet can be used to do the job. Keep it simple, but know the limitations of any tool you use. Also, keep in mind all of your stakeholders, including resources assigned, IT and business management, Quality Assurance and any others that need to know you are keeping an eye on things.

Use of ChatGPT in developing, managing & reporting on a validation project can be a great asset to getting things done more quickly & ensuring the most current information is available. ChatGPT can be used, for example, to search the most current FDA regulations to ensure your work will stand up to a compliance audit. It’s a powerful tool that can be used to generate validation deliverables, SOPs and other documents saving time and effort.

If you plan the project well, keeping it on track and reporting effectively to a variety of stakeholders will be much easier. The hardest part is keeping it simple while achieving the objectives, but this can be done fairly easily, especially by using a sound project management approach and incorporating ChatGPT into the work. Whatever tool you use, you can create a template for use with a system validation project by adjusting it to reflect the technology, skills, scope, timeline, resources and budget needed to stay on track and be successful.

Why should you Attend: Providing safe and effective medical devices, drugs, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about projects going on in industry and at FDA that take advantage of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT.

With newer technologies such as AI in the mix, it means opportunity for greater efficiency and efficacy, but also poses more challenges for companies that develop, test, and support software applications in the life science industries.

In this webinar, you will learn just how AI, ML and LLMs, such as ChatGPT can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive industry over the coming years.

Learn how using a project management framework to support your validation effort can provide great benefit in terms of efficiency and meeting targets for deliverables. It will allow you to manage scope, resources, timelines, deliverables and other aspects of the work involved.

With a project management approach, combined with the capabilities of ChatGPT, you are better able to govern the entire set of activities and tasks required to be performed by a large number and variety of resources. Know when specific skills are required, how to handle dependencies of any task on another, and take into account risks, assumptions, constraints and opportunities for improvement.

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the development or implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with FDA.

Areas Covered in the Session:

• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• What FDA Requires
• System Development Life Cycle (SDLC)
• GAMP5, 2nd Edition & Alignment with CSA
• Artificial Intelligence (AI) & Machine Learning (ML)
• ChatGPT
• ChatGPT & Project Management
• Learn how to create a Project Charter that clearly defines the work to be done
• Project Planning
• System Validation Planning, Execution & Documentation
• System Operations & Maintenance
• System Retirement
• Project Management tools & best practices
• Part 11 Compliance
• Data Integrity Compliance
• Learn how to identify scope and prevent scope "creep"
• Learn how to identify skills required
• Learn how to identify activities and tasks at the right level of granularity
• Understand how to stay on target with a reasonable timeline
• Learn how to use Project Management & ChatGPT to keep the team on track
• Learn how to identify dependencies of activities & tasks & maintain control
• Understand how to assess potential risk of project failure
• Understand how to define the assumptions and constraints related to the project
• Learn how to ensure you are able to get critical support from management, particularly when decisions must be made to keep the project on track
• Understand how to know your team, their knowledge/skills and capabilities
• Learn how managing a project requires you to exhibit some level of leadership to create a winning team and project
• Industry Best Practices
• Q&A

• Project Managers
• Risk Specialists
• 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