6-Hour Virtual Bootcamp on Shielding Your Medical Device Data: Proven Strategies to Outsmart Cyber Threats and Ensure FDA Compliance
Implement Advanced Risk Management, Develop A Robust SQA Plan, & Stay Ahead of Emerging Cybersecurity Threats!
Instructor :
Carolyn Troiano
Webinar ID:
11775
Date: JAN 13, 2025 (MON)
Start Time: 9 AM PT - 3 PM PT
Duration: 6 Hrs.
What you will learn
-
- Understand FDA Regulations And Guidance For Medical Device Cybersecurity Compliance
- Explore Types And Uses Of Software In Medical Devices
- Develop A Comprehensive Software Quality Assurance (SQA) Plan
- Prepare For FDA Inspections And Regulatory Oversight Effectively
- Ensure System Integrity With GxP And Computer System Validation
- Implement Advanced Risk Management And ….
-
- Understand FDA Regulations And Guidance For Medical Device Cybersecurity Compliance
- Explore Types And Uses Of Software In Medical Devices
- Develop A Comprehensive Software Quality Assurance (SQA) Plan
- Prepare For FDA Inspections And Regulatory Oversight Effectively
- Ensure System Integrity With GxP And Computer System Validation
- Implement Advanced Risk Management And Validation Strategies Using SDLC
- Discover Emerging Cybersecurity Trends And Develop A Response Strategy
Course Description
Elevate Your Compliance and Cybersecurity Acumen with Our Premier 1-Day Bootcamp on Medical Device Cybersecurity and FDA Compliance
In the rapidly evolving field of medical technology, the security and compliance of medical devices are not just regulatory requirements but are crucial to safeguarding patient safety and maintaining public trust.
Join us for an intensive 1-Day Bootcamp designed to transform you into an expert on the latest cybersecurity challenges and FDA regulatory insights.
Why This Bootcamp is Unmissable:
-
- Deep Dive into Regulatory Frameworks: Learn the intricacies of FDA regulations with a special focus on the latest guidelines impacting medical device cybersecurity. Our curriculum is meticulously crafted to provide you with comprehensive insights into critical standards like IEC 62304 and the FDA’s evolving cybersecurity policies.
- Expert-Led Sessions: Gain exclusive knowledge from industry leaders who bring years of firsthand experience in medical device compliance and cybersecurity. Their deep-dive sessions will cover complex scenarios and cutting-edge solutions to real-world challenges.
- Hands-On Strategies for Immediate Application: Through interactive workshops and case studies, you’ll develop actionable strategies to enhance your organization’s resilience against cyber threats. Learn how to implement robust cybersecurity frameworks and maintain continuous compliance with FDA regulations.
- Future Trends and Innovations: Stay ahead of the curve by understanding future threats and the latest innovations in device security. Explore how emerging technologies like AI and blockchain are reshaping device cybersecurity and what it means for compliance.
Key Takeaways:
By participating in this bootcamp, you will:
-
- Acquire a deep understanding of the latest FDA guidelines and how to apply them effectively to ensure compliance and device integrity.
- Develop critical cybersecurity skills to identify vulnerabilities, mitigate risks, and safeguard data.
- Enhance your professional value with advanced knowledge that positions you as a leader in your field.
Embrace the opportunity to lead with excellence in the cybersecurity and regulatory compliance of medical devices.
Join Now!
Elevate Your Compliance and Cybersecurity Acumen with Our Premier 1-Day Bootcamp on Medical Device Cybersecurity and FDA Compliance
In the rapidly evolving field of medical technology, the security and compliance of medical devices are not just regulatory requirements but are crucial to safeguarding patient safety and maintaining public trust.
Join us for an intensive 1-Day Bootcamp designed to transform you into an expert on the latest cybersecurity challenges and FDA regulatory insights.
Why This Bootcamp is Unmissable:
-
- Deep Dive into Regulatory Frameworks: Learn the intricacies of FDA regulations with a special focus on the latest guidelines impacting medical device cybersecurity. Our curriculum is meticulously crafted to provide you with comprehensive insights into critical standards like IEC 62304 and the FDA’s evolving cybersecurity policies.
- Expert-Led Sessions: Gain exclusive knowledge from industry leaders who bring years of firsthand experience in medical device compliance and cybersecurity. Their deep-dive sessions will cover complex scenarios and cutting-edge solutions to real-world challenges.
- Hands-On Strategies for Immediate Application: Through interactive workshops and case studies, you’ll develop actionable strategies to enhance your organization’s resilience against cyber threats. Learn how to implement robust cybersecurity frameworks and maintain continuous compliance with FDA regulations.
- Future Trends and Innovations: Stay ahead of the curve by understanding future threats and the latest innovations in device security. Explore how emerging technologies like AI and blockchain are reshaping device cybersecurity and what it means for compliance.
Key Takeaways:
By participating in this bootcamp, you will:
-
- Acquire a deep understanding of the latest FDA guidelines and how to apply them effectively to ensure compliance and device integrity.
- Develop critical cybersecurity skills to identify vulnerabilities, mitigate risks, and safeguard data.
- Enhance your professional value with advanced knowledge that positions you as a leader in your field.
Embrace the opportunity to lead with excellence in the cybersecurity and regulatory compliance of medical devices.
Join Now!
Why you should attend
-
- Are your medical devices prepared for the latest FDA cybersecurity mandates?
- Worried about your medical devices’ compliance with evolving FDA guidelines?
Adapt to an Evolving Landscape: The medical device industry is undergoing rapid evolution, driven by technological advancements and escalating cyber threats.
Join our 6-hour Virtual Bootcamp to gain cutting-edge insights on FDA’s 2024 updates. Learn to implement advanced risk management, develop a robust SQA plan, and stay ahead of emerging cybersecurity threats.
Address Key Industry Challenges:
-
- Increasing Complexity of Cyber Threats: As medical devices become more connected, they are exposed to a range of new vulnerabilities. This session will delve into the most recent threats and provide you with strategies to safeguard devices and patient data effectively.
- Regulatory Updates: With the FDA continually updating their compliance requirements, missing out on crucial updates can lead to severe repercussions. Our training ensures you remain updated on the latest regulatory changes and understand how to implement them.
Achieve Your Professional Objectives:
-
- Enhance Your Skills: Gain advanced knowledge and practical skills in both cybersecurity and regulatory compliance that are immediately applicable to your work.
- Reduce Risk: Learn to identify potential security risks early, implement stronger safeguards, and ensure continuous compliance, reducing the likelihood of costly breaches and compliance failures.
- Lead with Confidence: Empower yourself to take a proactive stance on cybersecurity, enhancing your leadership capabilities and making you a pivotal asset to your organization.
Bridge Theory and Practice: Through interactive discussions, case studies, and scenario-based learning, this bootcamp links theoretical knowledge with practical application, ensuring you can act decisively and effectively in real-world situations.
Invest in Your Future: Attending this bootcamp represents a strategic investment in your career. Beyond just meeting the minimum compliance standards, you’ll be equipped to lead initiatives that protect patient safety and uphold your organization’s integrity against emerging cyber threats.
Join us to transform your approach to medical device cybersecurity and compliance and position yourself as a leader in a critically important field.
Enroll Now!
-
- Are your medical devices prepared for the latest FDA cybersecurity mandates?
- Worried about your medical devices’ compliance with evolving FDA guidelines?
Adapt to an Evolving Landscape: The medical device industry is undergoing rapid evolution, driven by technological advancements and escalating cyber threats.
Join our 6-hour Virtual Bootcamp to gain cutting-edge insights on FDA’s 2024 updates. Learn to implement advanced risk management, develop a robust SQA plan, and stay ahead of emerging cybersecurity threats.
Address Key Industry Challenges:
-
- Increasing Complexity of Cyber Threats: As medical devices become more connected, they are exposed to a range of new vulnerabilities. This session will delve into the most recent threats and provide you with strategies to safeguard devices and patient data effectively.
- Regulatory Updates: With the FDA continually updating their compliance requirements, missing out on crucial updates can lead to severe repercussions. Our training ensures you remain updated on the latest regulatory changes and understand how to implement them.
Achieve Your Professional Objectives:
-
- Enhance Your Skills: Gain advanced knowledge and practical skills in both cybersecurity and regulatory compliance that are immediately applicable to your work.
- Reduce Risk: Learn to identify potential security risks early, implement stronger safeguards, and ensure continuous compliance, reducing the likelihood of costly breaches and compliance failures.
- Lead with Confidence: Empower yourself to take a proactive stance on cybersecurity, enhancing your leadership capabilities and making you a pivotal asset to your organization.
Bridge Theory and Practice: Through interactive discussions, case studies, and scenario-based learning, this bootcamp links theoretical knowledge with practical application, ensuring you can act decisively and effectively in real-world situations.
Invest in Your Future: Attending this bootcamp represents a strategic investment in your career. Beyond just meeting the minimum compliance standards, you’ll be equipped to lead initiatives that protect patient safety and uphold your organization’s integrity against emerging cyber threats.
Join us to transform your approach to medical device cybersecurity and compliance and position yourself as a leader in a critically important field.
Enroll Now!
Course Agenda
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
Session 1: Introduction and Foundation of Medical Device Cybersecurity (1.5 Hours)
-
- Overview of Software in Medical Devices: Types, Uses, and Recent FDA Focus
- Regulatory Landscape: Understanding the key guidance documents and FDA’s recent findings
- Introduction to IEC 62304 and its role in medical device cybersecurity
Session 2: Compliance Framework and Quality Assurance (1.5 Hours)
-
- Overview of FDA Guidance on Medical Device Cybersecurity and Other Relevant Regulations
- Developing and Implementing a Software Quality Assurance (SQA) Plan
- Preparation for FDA Regulatory Oversight: What to expect during inspections and how to prepare
Session 3: System Integrity and Advanced Compliance Strategies (1.5 Hours)
-
- Ensuring System and Data Integrity: Importance of GxP Systems and CSV
- Advanced Validation and Risk Management: SDLC Methodologies and GAMP®5 Software Categorization
- System Risk Assessment: Tools and Techniques
Session 4: Looking Ahead and Strategic Planning (1.5 Hours)
-
- Future Trends and Emerging Technologies in Medical Device Cybersecurity
- Case Study: Innovative Approaches to Cybersecurity
- Strategic Workshop: Creating a Cybersecurity Response Strategy
- Comprehensive Recap of Key Points and Final Q&A
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
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
Session 1: Introduction and Foundation of Medical Device Cybersecurity (1.5 Hours)
-
- Overview of Software in Medical Devices: Types, Uses, and Recent FDA Focus
- Regulatory Landscape: Understanding the key guidance documents and FDA’s recent findings
- Introduction to IEC 62304 and its role in medical device cybersecurity
Session 2: Compliance Framework and Quality Assurance (1.5 Hours)
-
- Overview of FDA Guidance on Medical Device Cybersecurity and Other Relevant Regulations
- Developing and Implementing a Software Quality Assurance (SQA) Plan
- Preparation for FDA Regulatory Oversight: What to expect during inspections and how to prepare
Session 3: System Integrity and Advanced Compliance Strategies (1.5 Hours)
-
- Ensuring System and Data Integrity: Importance of GxP Systems and CSV
- Advanced Validation and Risk Management: SDLC Methodologies and GAMP®5 Software Categorization
- System Risk Assessment: Tools and Techniques
Session 4: Looking Ahead and Strategic Planning (1.5 Hours)
-
- Future Trends and Emerging Technologies in Medical Device Cybersecurity
- Case Study: Innovative Approaches to Cybersecurity
- Strategic Workshop: Creating a Cybersecurity Response Strategy
- Comprehensive Recap of Key Points and Final Q&A
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
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Healthcare Leaders Seeking Proactive Measures Against Cyber Threats
- Compliance Officers Focused on Meeting the Latest FDA Standards
- IT Security Managers Aiming to Fortify Medical Device Cybersecurity
- Regulatory Affairs Specialists Needing Insights on FDA Cybersecurity Guidelines
- Medical Device Developers Looking to Embed Security from the Start
- Quality Assurance Professionals Focused on Risk Management and SQA Plans
- HR and Training Managers Creating Cybersecurity Training Paths for Teams
- Product Managers Striving to Align Products with Regulatory Compliance
- Innovation Officers Exploring Cutting-Edge Cybersecurity Technologies
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Healthcare Leaders Seeking Proactive Measures Against Cyber Threats
- Compliance Officers Focused on Meeting the Latest FDA Standards
- IT Security Managers Aiming to Fortify Medical Device Cybersecurity
- Regulatory Affairs Specialists Needing Insights on FDA Cybersecurity Guidelines
- Medical Device Developers Looking to Embed Security from the Start
- Quality Assurance Professionals Focused on Risk Management and SQA Plans
- HR and Training Managers Creating Cybersecurity Training Paths for Teams
- Product Managers Striving to Align Products with Regulatory Compliance
- Innovation Officers Exploring Cutting-Edge Cybersecurity Technologies
Instructor Profile
Carolyn (McKillop) 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. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
