Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations

Description

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen some trends toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations that have more recently begun to be used more heavily in life science companies.

Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT are beginning to find a presence at these companies.

While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much more activity related to AI use in software applications used to develop, produce, test, and manage life science products with quality and compliance.As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where artificial intelligence (AI) and machine learning (ML) are becoming more prevalent.

Why Should You Attend:

Providing safe and effective FDA-regulated products is in the best interests of all those involved in their development, manufacturing, testing, and distribution. 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. 

AI can hallucinate, and show bias and performance drift. The human expert must be able to critically assess the output and make the judgment calls for better decisions, quality, and compliance, and to optimize ROI.

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.In particular, you’ll learn about quality metrics enhanced through AI, and how these can further streamline activities and identify and mitigate risks before they are realized.

Areas Covered in the Session :

• Moving from lagging metrics to real-time digital quality signals
• Identifying the right metrics for GxP systems using risk-based quality principles
• Using AI/ML to detect trends, deviations, anomalies, and drift early
• Building dashboards that support data integrity, electronic records, and risk-based decision-making
• How analytics plug into the SDLC & GAMP 5 (Second Edition) control strategy
• Ensuring data integrity in metrics pipelines and aggregation layers
• Supplier-provided analytics & what FDA expects you to verify
• Presenting digital quality metrics during regulatory inspections and audits
• Understanding AI potential for hallucination, bias, and performance drift
• Ensuring a human with deep and broad knowledge provides the necessary guardrail to critically assess the output and make better decisions

Who Should Attend:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).

Functions that are applicable include research and development, manufacturing, Quality Control testing, distribution, clinical trial management, sample labeling, adverse events management, and post-marketing surveillance. Whether involved in software development, implementation, testing, validation, maintenance or use of AI-enabled solutions, you will find a wealth of knowledge to enhance your ability to use these technologies with maximum effectiveness. 

Those using these systems, in particular, must understand their role as the human guardrail of AI, critically assessing the outcomes, making intelligent judgment calls, and ensuring better decisions. It’s not just about using these AI solutions, it’s about using them effectively and by critically thinking about your role and accountability to ensure you optimize quality, compliance, and ROI.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts and Managers
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• 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
• 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 internal inspection

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. It will also help those in software development companies who support the life science industries.

Course Director: CAROLYN TROIANO