Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
Unlock the Potential of AI with Compliance Confidence!
Instructor :
Carolyn Troiano
Webinar ID:
10055
Date: DEC 25, 2024 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- AI’s Impact in Life Sciences: Leading Safer, Effective Product Developments.
- Industry Challenges: Unveiling Current Vulnerabilities.
- FDA’s Cyberthreat Strategy: Addressing Technological Threats.
- Risk Impact: Understanding Threats to …
- AI’s Impact in Life Sciences: Leading Safer, Effective Product Developments.
- Industry Challenges: Unveiling Current Vulnerabilities.
- FDA’s Cyberthreat Strategy: Addressing Technological Threats.
- Risk Impact: Understanding Threats to Data, Products, and Patient Safety.
- Best Practices: Implementing AI with FDA Compliance.
- Q&A Session: Addressing Your Specific Queries.
Course Description
In an era where AI and ML technologies are rapidly transforming the healthcare landscape, understanding the current industry and regulatory trends is more crucial than ever!!
The FDA’s adaptive stance towards the regulation of AI-enabled medical devices showcases the significance of staying at the forefront of compliance and innovation.
As these technologies evolve, so do the challenges and opportunities for companies operating within FDA-regulated environments.
This makes our upcoming webinar not just timely but essential for professionals looking to navigate the complexities of integrating AI and ML into their operational processes.
Unlock the potential of AI with compliance confidence. In this 1.5-hour session, you’ll delve into:
- The FDA’s Evolving Framework: Understand how the FDA’s review process is adapting to AI’s unique capabilities to evolve and learn from new data.
- Current and Future AI Applications: Explore the expanding role of AI in healthcare, from diagnostics to personalized medicine, and the implications for regulatory compliance.
- Balancing Innovation and Risk: Learn to navigate the fine line where the benefits of AI-driven products decisively outweigh the risks.
Key Takeaways:
- Deep Dive into Regulatory Changes: Insight into the dynamic regulatory landscape for AI and ML technologies.
- Ethical AI: Strategies for ethical consideration and bias mitigation in AI applications.
- Real-World Applications: Learn from case studies showcasing successful compliance and implementation strategies.
- Continuous Monitoring: Understand the importance of post-market surveillance and continuous monitoring for maintaining compliance.
This webinar is designed for professionals eager to master the regulatory challenges of using AI and ML in healthcare.
Equip yourself with the knowledge to future-proof your compliance strategies, ensuring your innovations are impactful, compliant, and ethically responsible.
Join Now!
In an era where AI and ML technologies are rapidly transforming the healthcare landscape, understanding the current industry and regulatory trends is more crucial than ever!!
The FDA’s adaptive stance towards the regulation of AI-enabled medical devices showcases the significance of staying at the forefront of compliance and innovation.
As these technologies evolve, so do the challenges and opportunities for companies operating within FDA-regulated environments.
This makes our upcoming webinar not just timely but essential for professionals looking to navigate the complexities of integrating AI and ML into their operational processes.
Unlock the potential of AI with compliance confidence. In this 1.5-hour session, you’ll delve into:
- The FDA’s Evolving Framework: Understand how the FDA’s review process is adapting to AI’s unique capabilities to evolve and learn from new data.
- Current and Future AI Applications: Explore the expanding role of AI in healthcare, from diagnostics to personalized medicine, and the implications for regulatory compliance.
- Balancing Innovation and Risk: Learn to navigate the fine line where the benefits of AI-driven products decisively outweigh the risks.
Key Takeaways:
- Deep Dive into Regulatory Changes: Insight into the dynamic regulatory landscape for AI and ML technologies.
- Ethical AI: Strategies for ethical consideration and bias mitigation in AI applications.
- Real-World Applications: Learn from case studies showcasing successful compliance and implementation strategies.
- Continuous Monitoring: Understand the importance of post-market surveillance and continuous monitoring for maintaining compliance.
This webinar is designed for professionals eager to master the regulatory challenges of using AI and ML in healthcare.
Equip yourself with the knowledge to future-proof your compliance strategies, ensuring your innovations are impactful, compliant, and ethically responsible.
Join Now!
Why you should attend
If you’re tasked with ensuring your products are developed, manufactured, and maintained in a manner that preemptively addresses cybersecurity threats, this webinar is an essential resource.
Ensuring the safety and efficacy of medical devices, pharmaceuticals, and other FDA-regulated products is paramount for everyone involved in their lifecycle—from development and manufacturing to testing and distribution.
Today, one of the most significant challenges threatening this safety is cybersecurity risks, with cyberattacks capable of compromising device functionality and patient safety.
Key Benefits of Attending:
- Understand the Cybersecurity Landscape: Learn about the current threats to medical devices and software applications, including the impact of cyberattacks on code and device functionality.
- AI’s Role in Enhancing Security: Discover how Artificial Intelligence can revolutionize the Software Development Life Cycle (SDLC), increasing the efficiency and effectiveness of developing, testing, and supporting life science software applications.
- Strategies for Prevention and Mitigation: Explore comprehensive strategies for identifying, preventing, and mitigating cybersecurity risks, ensuring your products remain safe and functional.
- Industry Best Practices: Gain insights into the best practices within the industry for combating cybersecurity threats and safeguarding your operations
Join us to arm yourself with the knowledge and tools to navigate the complexities of cybersecurity in the era of AI and digital innovation.
Enroll Now!
If you’re tasked with ensuring your products are developed, manufactured, and maintained in a manner that preemptively addresses cybersecurity threats, this webinar is an essential resource.
Ensuring the safety and efficacy of medical devices, pharmaceuticals, and other FDA-regulated products is paramount for everyone involved in their lifecycle—from development and manufacturing to testing and distribution.
Today, one of the most significant challenges threatening this safety is cybersecurity risks, with cyberattacks capable of compromising device functionality and patient safety.
Key Benefits of Attending:
- Understand the Cybersecurity Landscape: Learn about the current threats to medical devices and software applications, including the impact of cyberattacks on code and device functionality.
- AI’s Role in Enhancing Security: Discover how Artificial Intelligence can revolutionize the Software Development Life Cycle (SDLC), increasing the efficiency and effectiveness of developing, testing, and supporting life science software applications.
- Strategies for Prevention and Mitigation: Explore comprehensive strategies for identifying, preventing, and mitigating cybersecurity risks, ensuring your products remain safe and functional.
- Industry Best Practices: Gain insights into the best practices within the industry for combating cybersecurity threats and safeguarding your operations
Join us to arm yourself with the knowledge and tools to navigate the complexities of cybersecurity in the era of AI and digital innovation.
Enroll Now!
Course Agenda
- Discover how AI is revolutionizing the life sciences industry, leading the charge towards safer, more effective, and beneficial products.
- Explore the challenges and vulnerabilities currently facing the industry and how they impact product safety and efficacy.
- Understand the FDA’s response to the surge in cyberthreats brought about by emerging technologies, and what further measures are being considered.
- Gauge the potential impact and risks to data, processes, products, and patient safety posed by these cyberthreats.
- Learn about industry best practices for implementing and validating AI applications, meeting FDA Part 11, and ensuring data integrity to enhance operational efficiency and effectiveness.
- Interactive Q&A Session: Have your questions answered and gain deeper insights into the topics discussed.
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
- Discover how AI is revolutionizing the life sciences industry, leading the charge towards safer, more effective, and beneficial products.
- Explore the challenges and vulnerabilities currently facing the industry and how they impact product safety and efficacy.
- Understand the FDA’s response to the surge in cyberthreats brought about by emerging technologies, and what further measures are being considered.
- Gauge the potential impact and risks to data, processes, products, and patient safety posed by these cyberthreats.
- Learn about industry best practices for implementing and validating AI applications, meeting FDA Part 11, and ensuring data integrity to enhance operational efficiency and effectiveness.
- Interactive Q&A Session: Have your questions answered and gain deeper insights into the topics discussed.
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Maximize the Learning Experience in A Group Setting!
This webinar is specifically designed for professionals in the FDA-regulated industries—pharmaceutical, medical device, biological, animal health, and tobacco.
It is particularly relevant for individuals involved in:
- Research and Development
- Manufacturing
- Quality Control
- Distribution
- Clinical Testing and Management
- Adverse Events Management
- Post-Marketing Surveillance
Maximize the Learning Experience in A Group Setting!
This webinar is specifically designed for professionals in the FDA-regulated industries—pharmaceutical, medical device, biological, animal health, and tobacco.
It is particularly relevant for individuals involved in:
- Research and Development
- Manufacturing
- Quality Control
- Distribution
- Clinical Testing and Management
- Adverse Events Management
- Post-Marketing Surveillance
Instructor Profile
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.
