To enhance the delivery of high-quality products in accordance with FDA regulations, the life science sectors—pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products—continue to use innovative technologies.
Artificial Intelligence (AI) is starting to establish itself at life science organizations, in addition to some tendencies toward the usage of cloud services, Software-as-a-Service (SaaS) solutions, and other technological advancements that have more recently started to be employed more heavily in these companies.
The use of AI in software applications used to create, produce, test, and manage life science goods with quality and compliance is becoming increasingly prevalent, even if life science organizations still tend to lag behind other markets in adopting these technologies.
In contexts where artificial intelligence (AI) is becoming more common, computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance are vital as the rate of technological innovation and evolution increases.
Over the past ten years, the FDA has been concerned about the lack of compliance with Part 11 and data integrity regulations. For these crucial areas of compliance, out-of-compliance citations, such as Form 483s and Warning Letters, have increased dramatically over this time. However, why?
It has become more clear from conversations with clients and stakeholders at conferences and meetings that management is pressuring the majority of industry performers to complete more work in less time and with fewer resources. This encourages further discussion about the application of AI in software development, testing, and support and keeps performers looking for quicker and simpler ways to do tasks.
It's time to start the AI revolution and keep providing high-quality products that comply with regulations to satisfy consumer demands by giving them access to safer, more effective, and more inventive products—all of which are FDA priority areas.
Why should you attend:
It is in the best interests of everyone involved in the creation, production, testing, and distribution of pharmaceuticals, medical devices, and other FDA-regulated goods to provide safe and efficient products. Cyberattacks that can severely disrupt coding and device performance are one of the biggest threats to these devices operating safely and effectively today. The top priority is to prevent these attacks by locating the sources of risks and eliminating them before they have a chance to manifest. Additionally, businesses who create, test, and maintain software applications for the life science sectors have additional difficulties as a result of the inclusion of more recent technology like artificial intelligence.
You will discover in this webinar how artificial intelligence (AI) may boost the efficacy and efficiency of software development life cycle (SDLC) tasks, facilitating the supply and maintenance of computer systems that will propel industry in the years to come.
Areas covered in the session:
Learning Goals: The following are the main goals of this webinar:
Who should attend this:
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:
Personnel in the following roles will benefit:
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
