Instructor :
John E Lincoln

Webinar ID:
12548

In today’s connected world, cybersecurity for medical devices is no longer optional—it’s essential.

As the FDA’s regulations evolve to address new and ongoing risks, medical product manufacturers must keep pace to ensure compliance and protect patient data.

This 60-minute webinar will guide you through the latest FDA cybersecurity requirements and provide actionable strategies for safeguarding your devices and data.

Key Takeaways:

• • Understand Critical Regulations:
    • • Dive into foundational guidelines, including 21 CFR Part 11 in the U.S. and Annex 11 in Europe, and learn about the latest FDA guidance documents impacting cybersecurity for medical products.

• • Enhance CGMP Compliance:
    • • Discover how to align with CGMP standards while addressing the FDA’s growing concerns around cybersecurity violations, seen frequently in device inspections and submissions.

• • Address BYOD Challenges:
    • • Learn how Bring Your Own Device (BYOD) policies affect data integrity and what strategies can mitigate risks associated with personal devices like laptops, smartphones, and tablets.

• • Mitigate Cloud-Based Vulnerabilities:
    • • Gain insights into securing cloud-based software for CGMP tasks, data storage, and retrieval, which pose unique security challenges for regulated environments.

Join us to stay informed on FDA mandates, strengthen your cybersecurity practices, and maintain regulatory compliance in an increasingly digital landscape.

Enroll Now!

In today’s connected world, cybersecurity for medical devices is no longer optional—it’s essential.

As the FDA’s regulations evolve to address new and ongoing risks, medical product manufacturers must keep pace to ensure compliance and protect patient data.

This 60-minute webinar will guide you through the latest FDA cybersecurity requirements and provide actionable strategies for safeguarding your devices and data.

Key Takeaways:

• • Understand Critical Regulations:
    • • Dive into foundational guidelines, including 21 CFR Part 11 in the U.S. and Annex 11 in Europe, and learn about the latest FDA guidance documents impacting cybersecurity for medical products.

• • Enhance CGMP Compliance:
    • • Discover how to align with CGMP standards while addressing the FDA’s growing concerns around cybersecurity violations, seen frequently in device inspections and submissions.

• • Address BYOD Challenges:
    • • Learn how Bring Your Own Device (BYOD) policies affect data integrity and what strategies can mitigate risks associated with personal devices like laptops, smartphones, and tablets.

• • Mitigate Cloud-Based Vulnerabilities:
    • • Gain insights into securing cloud-based software for CGMP tasks, data storage, and retrieval, which pose unique security challenges for regulated environments.

Join us to stay informed on FDA mandates, strengthen your cybersecurity practices, and maintain regulatory compliance in an increasingly digital landscape.

Enroll Now!

In an era of rising cybersecurity threats to medical devices, electronic records, and manufacturing systems, staying ahead of FDA requirements is crucial.

With recent updates to key FDA guidance documents, medical product manufacturers face increased scrutiny and complex challenges in maintaining cybersecurity and CGMP compliance.

This webinar is designed to help you navigate these challenges with clarity and confidence.

By attending, you will:

• • Stay Compliant with FDA Guidance:
    • Gain insights into critical FDA documents, including:
      • Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
      • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
      • Postmarket Management of Cybersecurity in Medical Devices

• • Protect Against Security Risks:
    • • Understand how automatic updates, upgrades, and patches can introduce vulnerabilities that compromise data integrity, potentially impacting CGMP compliance and patient safety.

• • Master Cybersecurity Compliance:
    • • Learn effective techniques and tools to build cybersecurity into CGMP practices, ensuring regulatory compliance while reducing risks of data breaches and system failures.

• • Navigate Complex Responsibilities:
    • • Explore the role of system administrators and the importance of managing cybersecurity across all stages—design, production, and post-market—to prevent compromised systems.

This session will empower you with actionable steps to enhance cybersecurity measures, safeguard critical data, and meet FDA expectations, positioning you as a proactive leader in protecting patient safety and ensuring regulatory compliance.

Don’t miss this opportunity to strengthen your cybersecurity strategy and stay ahead in a rapidly evolving regulatory landscape.

Join Now!

In an era of rising cybersecurity threats to medical devices, electronic records, and manufacturing systems, staying ahead of FDA requirements is crucial.

With recent updates to key FDA guidance documents, medical product manufacturers face increased scrutiny and complex challenges in maintaining cybersecurity and CGMP compliance.

This webinar is designed to help you navigate these challenges with clarity and confidence.

By attending, you will:

• • Stay Compliant with FDA Guidance:
    • Gain insights into critical FDA documents, including:
      • Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
      • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
      • Postmarket Management of Cybersecurity in Medical Devices

• • Protect Against Security Risks:
    • • Understand how automatic updates, upgrades, and patches can introduce vulnerabilities that compromise data integrity, potentially impacting CGMP compliance and patient safety.

• • Master Cybersecurity Compliance:
    • • Learn effective techniques and tools to build cybersecurity into CGMP practices, ensuring regulatory compliance while reducing risks of data breaches and system failures.

• • Navigate Complex Responsibilities:
    • • Explore the role of system administrators and the importance of managing cybersecurity across all stages—design, production, and post-market—to prevent compromised systems.

This session will empower you with actionable steps to enhance cybersecurity measures, safeguard critical data, and meet FDA expectations, positioning you as a proactive leader in protecting patient safety and ensuring regulatory compliance.

Don’t miss this opportunity to strengthen your cybersecurity strategy and stay ahead in a rapidly evolving regulatory landscape.

Join Now!

1. Introduction to FDA Cybersecurity Expectations

• • Overview of the evolving regulatory landscape
  • Key drivers behind FDA’s focus on medical device cybersecurity

2. Understanding Key FDA Guidance Documents

• • Foundational documents:
    • • Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
      • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
      • Postmarket Management of Cybersecurity in Medical Devices

• • Recent updates and their practical implications

3. FDA’s Regulatory and Enforcement Strategies

• • How the FDA evaluates cybersecurity during inspections and reviews
  • Real-world case examples of compliance failures and enforcement actions

4. Managing Network Vulnerabilities

• • Common vulnerabilities affecting medical devices and electronic records
  • Risk mitigation techniques and preventive controls

5. Addressing Cloud-Based Challenges and Automatic Updates

• • Security considerations for cloud-hosted CGMP applications
  • Risks of automatic updates, patches, and remote access tools

6. Cybersecurity Integration in Design and Development

• • Incorporating security into design controls and risk management
  • Tools and practices for secure product development

7. Industry Standards and Frameworks

• • Alignment with NIST guidelines, ISO standards, and global best practices
  • How these frameworks influence FDA expectations

8. Verification, Validation, and Documentation

• • Cybersecurity-specific testing and validation protocols
  • Documentation practices for audits and submissions

9. Cybersecurity Requirements in FDA Device Submissions

• • Essential elements for premarket submissions
  • Demonstrating security controls in technical documentation

10. Final Q&A and Key Takeaways

• • Clarify doubts with the expert
  • Reinforce actionable insights and compliance strategies

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 FDA Cybersecurity Expectations

• • Overview of the evolving regulatory landscape
  • Key drivers behind FDA’s focus on medical device cybersecurity

2. Understanding Key FDA Guidance Documents

• • Foundational documents:
    • • Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
      • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
      • Postmarket Management of Cybersecurity in Medical Devices

• • Recent updates and their practical implications

3. FDA’s Regulatory and Enforcement Strategies

• • How the FDA evaluates cybersecurity during inspections and reviews
  • Real-world case examples of compliance failures and enforcement actions

4. Managing Network Vulnerabilities

• • Common vulnerabilities affecting medical devices and electronic records
  • Risk mitigation techniques and preventive controls

5. Addressing Cloud-Based Challenges and Automatic Updates

• • Security considerations for cloud-hosted CGMP applications
  • Risks of automatic updates, patches, and remote access tools

6. Cybersecurity Integration in Design and Development

• • Incorporating security into design controls and risk management
  • Tools and practices for secure product development

7. Industry Standards and Frameworks

• • Alignment with NIST guidelines, ISO standards, and global best practices
  • How these frameworks influence FDA expectations

8. Verification, Validation, and Documentation

• • Cybersecurity-specific testing and validation protocols
  • Documentation practices for audits and submissions

9. Cybersecurity Requirements in FDA Device Submissions

• • Essential elements for premarket submissions
  • Demonstrating security controls in technical documentation

10. Final Q&A and Key Takeaways

• • Clarify doubts with the expert
  • Reinforce actionable insights and compliance strategies

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.

Everybody benefits from watching this. Even better when done as a group!

• • Regulatory Affairs Leaders Seeking to Strengthen Cybersecurity Compliance
  • Quality Assurance Managers Aiming to Minimize Risk of Compliance Violations
  • IT Directors Responsible for Protecting Sensitive Medical Device Data
  • Product Development Heads Focused on Building Secure Medical Devices
  • System Administrators Who Manage Device and Software Security Updates
  • Compliance Officers Concerned with CGMP Adherence and Cybersecurity
  • HR and Training Leaders Developing Cybersecurity Awareness Among Staff
  • Medical Device Consultants Helping Clients Meet FDA Cybersecurity Standards
  • Manufacturing Executives Committed to Safeguarding Product Integrity

Everybody benefits from watching this. Even better when done as a group!

• • Regulatory Affairs Leaders Seeking to Strengthen Cybersecurity Compliance
  • Quality Assurance Managers Aiming to Minimize Risk of Compliance Violations
  • IT Directors Responsible for Protecting Sensitive Medical Device Data
  • Product Development Heads Focused on Building Secure Medical Devices
  • System Administrators Who Manage Device and Software Security Updates
  • Compliance Officers Concerned with CGMP Adherence and Cybersecurity
  • HR and Training Leaders Developing Cybersecurity Awareness Among Staff
  • Medical Device Consultants Helping Clients Meet FDA Cybersecurity Standards
  • Manufacturing Executives Committed to Safeguarding Product Integrity