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!

• • Overview of Key FDA Guidance Documents on Cybersecurity: Understand foundational FDA guidance documents and the most recent updates impacting cybersecurity for medical devices.
  • FDA’s Regulatory and Enforcement Approaches: Explore the FDA’s approach to enforcing cybersecurity compliance, including case examples of regulatory actions and the implications for manufacturers.
  • Identifying and Addressing Network Vulnerabilities: Learn about network vulnerabilities that impact medical devices and electronic records, with strategies for mitigating these risks.
  • Challenges of Cloud-Based Solutions and Automatic Updates: Examine the unique security concerns associated with cloud-based software, automatic updates, and how these can compromise CGMP compliance.
  • Cybersecurity Requirements in Design and Development: Discover design controls, security tools, and best practices to incorporate cybersecurity at every stage of medical device development.
  • NIST Guidelines and Related Cybersecurity Standards: Review the National Institute of Standards and Technology (NIST) guidelines and other industry standards that influence FDA cybersecurity expectations.
  • Verification, Validation, and Documentation Requirements: Understand the unique verification and validation requirements for cybersecurity, along with essential documentation practices to ensure compliance.
  • FDA-Specific Requirements for Device Submissions: Gain insights into the cybersecurity requirements for FDA device submissions, including key elements needed to satisfy regulatory expectations.

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.

• • Overview of Key FDA Guidance Documents on Cybersecurity: Understand foundational FDA guidance documents and the most recent updates impacting cybersecurity for medical devices.
  • FDA’s Regulatory and Enforcement Approaches: Explore the FDA’s approach to enforcing cybersecurity compliance, including case examples of regulatory actions and the implications for manufacturers.
  • Identifying and Addressing Network Vulnerabilities: Learn about network vulnerabilities that impact medical devices and electronic records, with strategies for mitigating these risks.
  • Challenges of Cloud-Based Solutions and Automatic Updates: Examine the unique security concerns associated with cloud-based software, automatic updates, and how these can compromise CGMP compliance.
  • Cybersecurity Requirements in Design and Development: Discover design controls, security tools, and best practices to incorporate cybersecurity at every stage of medical device development.
  • NIST Guidelines and Related Cybersecurity Standards: Review the National Institute of Standards and Technology (NIST) guidelines and other industry standards that influence FDA cybersecurity expectations.
  • Verification, Validation, and Documentation Requirements: Understand the unique verification and validation requirements for cybersecurity, along with essential documentation practices to ensure compliance.
  • FDA-Specific Requirements for Device Submissions: Gain insights into the cybersecurity requirements for FDA device submissions, including key elements needed to satisfy regulatory expectations.

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