Description

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 AI is becoming prevalent.

FDA became alarmed by the lack of compliance to meet data integrity and Part 11 requirements during the last decade. Out of compliance citations during this period, including Form 483s and Warning Letters have skyrocketed. But why?

Based on discussions with clients and stakeholders at conferences and meetings, it has become more and more obvious that most of the performers in industry are under management pressure to do more work with fewer resources and in less time. This continues to lead performers to seek faster and easier ways to get the work done, causing them to rush through their work, resulting in unforced errors, and leading some to even take shortcuts that could lead to findings of fraud. Being optimistic about this, it also opens the door for more serious conversation around the use of AI and other technologies in software development, testing, and support. This is compounded further by the greater efficiencies promised by following CSA and removing work that does not add value while assuring risk is appropriately assessed and mitigated.

As we find ourselves in the midst of technology and compliance revolutions, It is time to prepare ourselves and be ready to leverage them to deliver quality products that meet the needs of consumers. Providing consumers with newer, safer, and more innovative and effective products is key to both FDA’s and industry’s focus on public safety.

Learning Objectives:-

This webinar includes the following key objectives:

• Learn about Artificial Intelligence (AI) and Machine Learning (ML) and how they can be incorporated into computer system software used in FDA-regulated activities
• Learn the best approach to validating and maintaining computer systems that incorporate AI and ML technology
• Understand the challenges of using AI and ML in computer systems used in FDA-regulated activities
• Learn about traditional Computer System Validation (CSV) and the more current draft guidance from FDA on Computer Software Assurance (CSA)
• Learn about GAMP®5, 2^nd Edition and how it aligns with both CSA and with AI and ML solutions
• Learn about 21 CFR Part 11 requirements for FDA compliance and a streamlined approach to ensuring systems are fully tested/verified during validation
• Learn about data integrity requirements for FDA compliance and a streamlined approach to ensuring systems are fully tested/verified during validation
• Learn about how to comply with FDA while using Commercial Off-the-Shelf (COTS) software applications, cloud-based systems and Software-as-a-Service (SaaS) solutions
• Learn about current FDA compliance trends
• Learn about current industry best practices
• Q&A

Areas Covered:-

This webinar includes the following key areas:

• Artificial Intelligence (AI)
• Machine Learning (ML)
• Large Language Models (LLMs), such as ChatGPT
• FDA Compliance for Computer System Validation
• Traditional Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• System Development Life Cycle (SDLC) Methodology
• GAMP^®5, 2^nd Edition
• GAMP^®5 Software Categories
• 21 CFR Part 11, FDA Guidance for Using Electronic Records/Electronic Signatures in Regulated Computer Systems
• Data Integrity Compliance
• Critical Thinking
• Risk Assessment
• Risk-Based Approach to Validation
• Commercial-Off-the-Shelf (COTS) Software
• Software-as-a-Service (SaaS) Solutions
• Cloud Services
• Automated Testing
• Systems and Organizational Control (SOC) Certification
• Vendor Audit
• Periodic System Review
• FDA Compliance Trends
• Current Industry Best Practices
• Q&A.

Background:-

The life science industries, including pharmaceutical, medical device, biotechnology, biological, tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.

We have seen the recent trend in industry toward using cloud-based services, Software-as-a-Service (SaaS) solutions, and other technical innovations. More recently, we have begun to see newer, emerging technologies including Artificial Intelligence (AI), Machine Learning (ML) algorithms & Large Language Models (LLMs), such as ChatGPT begin to find a presence within 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 greater use of AI in the development, testing, release & management of life science products with quality and compliance. This is most predominant in the medical device industry, where we find both medical devices that include software as a product component & Software-as-a-Medical-Device (SaMD) products that function as a medical device without the need for any hardware.

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. Current industry drivers, including the rising demand for healthcare, expansion of specialty medicines & physician shortages require key strategies to alleviate pressures & accelerate the delivery of safe & effective products to the marketplace. As demand surges & complexity of cases requires approaches leveraging the latest medical knowledge, rapid access to accurate information is essential to quality.

Only by leveraging the latest in innovative technology will the industry catch up to where delivery is meeting demand. Along with companies, FDA has begun pilot programs using these technologies and is working to develop the appropriate regulatory framework to ensure products are safe & effective. Several discussion papers have been issued over the last few years & updated based on stakeholder feedback. Ultimately, these will be key elements for driving success.

We will compare traditional Computer System Validation (CSV) with Computer Software Assurance (CSA), the latter of which is the subject of FDA’s September 2022 draft guidance for industry. We will talk about the changes in the newer GAMP®5, 2^nd Edition & how these align with CSA. While CSA remains a draft guidance, it will likely be finalized in the near future & companies must be prepared.

In addition to technology, we will discuss a variety of current trends in FDA compliance & enforcement. Over the last decade, we have seen an increase in citations related to 21 CFR Part 11 (electronic records/signatures) & data integrity (ALCOA+ principles) deficiencies. Laboratory areas have been the subject of many FDA findings, particularly around audit trail management & use, risk assessment, access controls & security.

Who Should Attend:-

Personnel in the following roles will benefit:

• Information Technology (IT) Analysts
• IT Software Developers & Testers
• 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.