Instructor :
Carolyn Troiano

Webinar ID:
10055

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:

1. 1. Deep Dive into Regulatory Changes: Insight into the dynamic regulatory landscape for AI and ML technologies.
   2. Ethical AI: Strategies for ethical consideration and bias mitigation in AI applications.
   3. Real-World Applications: Learn from case studies showcasing successful compliance and implementation strategies.
   4. 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:

1. 1. Deep Dive into Regulatory Changes: Insight into the dynamic regulatory landscape for AI and ML technologies.
   2. Ethical AI: Strategies for ethical consideration and bias mitigation in AI applications.
   3. Real-World Applications: Learn from case studies showcasing successful compliance and implementation strategies.
   4. 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!

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!

1. Introduction to AI and ML in Life Sciences

• • Overview of AI/ML technologies and their growing role in regulated environments
  • Key drivers of AI adoption in healthcare and life sciences

2. Current Industry Challenges and Vulnerabilities

• • Cybersecurity threats and their impact on product integrity and patient safety
  • Common pitfalls in integrating AI into FDA-regulated systems

3. Regulatory Landscape and the FDA’s Adaptive Framework

• • How the FDA is evolving its policies to address AI/ML systems
  • Insights into the Pre-Cert program and real-world evidence (RWE) integration
  • Key compliance requirements for AI-enabled medical products

4. Risk Assessment and Ethical Considerations

• • Strategies to evaluate potential risks to data, processes, and patients
  • Managing algorithmic bias and ensuring transparency in AI models

5. Best Practices for AI Validation and Compliance

• • Aligning with FDA 21 CFR Part 11 and data integrity standards
  • Lifecycle validation of AI systems, from development to post-market monitoring
  • Case studies showcasing successful implementation and compliance

6. Interactive Q&A Session

• • Get expert answers to your specific challenges
  • Discuss real-world applications and tailored solutions

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

1. Introduction to AI and ML in Life Sciences

• • Overview of AI/ML technologies and their growing role in regulated environments
  • Key drivers of AI adoption in healthcare and life sciences

2. Current Industry Challenges and Vulnerabilities

• • Cybersecurity threats and their impact on product integrity and patient safety
  • Common pitfalls in integrating AI into FDA-regulated systems

3. Regulatory Landscape and the FDA’s Adaptive Framework

• • How the FDA is evolving its policies to address AI/ML systems
  • Insights into the Pre-Cert program and real-world evidence (RWE) integration
  • Key compliance requirements for AI-enabled medical products

4. Risk Assessment and Ethical Considerations

• • Strategies to evaluate potential risks to data, processes, and patients
  • Managing algorithmic bias and ensuring transparency in AI models

5. Best Practices for AI Validation and Compliance

• • Aligning with FDA 21 CFR Part 11 and data integrity standards
  • Lifecycle validation of AI systems, from development to post-market monitoring
  • Case studies showcasing successful implementation and compliance

6. Interactive Q&A Session

• • Get expert answers to your specific challenges
  • Discuss real-world applications and tailored solutions

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Maximize the Learning Experience in A Group Setting!

• • Regulatory Affairs Professionals In Life Sciences Industry
  • Quality Assurance And Compliance Managers In Healthcare
  • IT And Data Security Leads In Pharma Companies
  • Medical Device Developers Using AI And ML
  • Clinical Research And Product Development Specialists
  • Digital Health Innovators And Tech Strategy Leaders
  • Validation Engineers Working On Intelligent Systems
  • Professionals Navigating FDA-Regulated Tech Environments

Maximize the Learning Experience in A Group Setting!

• • Regulatory Affairs Professionals In Life Sciences Industry
  • Quality Assurance And Compliance Managers In Healthcare
  • IT And Data Security Leads In Pharma Companies
  • Medical Device Developers Using AI And ML
  • Clinical Research And Product Development Specialists
  • Digital Health Innovators And Tech Strategy Leaders
  • Validation Engineers Working On Intelligent Systems
  • Professionals Navigating FDA-Regulated Tech Environments