6-Hour Virtual Bootcamp on Medical Device Cybersecurity: Shield Your Data, Ensure FDA Compliance, Lead with Confidence
Implement Advanced Risk Management, Develop A Robust SQA Plan, & Stay Ahead of Emerging Cybersecurity Threats!
Instructor :
Carolyn Troiano
Webinar ID:
12809
Date: MAR 06, 2025 (THU)
Start Time: 9 AM PT - 3 PM PT
Duration: 6 Hrs.
What will you learn
-
- Understand FDA Guidelines And IEC 62304 For Cybersecurity Compliance.
- Develop And Implement A Robust Software Quality Assurance (SQA) Plan.
- Prepare For FDA Audits With Confidence And Effective Strategies.
- Ensure System Integrity Using GxP Systems And CSV Best Practices.
- Master Advanced Risk Management Through SDLC And GAMP®5 Techniques.
- Explore Future Cybersecurity Trends And ….
-
- Understand FDA Guidelines And IEC 62304 For Cybersecurity Compliance.
- Develop And Implement A Robust Software Quality Assurance (SQA) Plan.
- Prepare For FDA Audits With Confidence And Effective Strategies.
- Ensure System Integrity Using GxP Systems And CSV Best Practices.
- Master Advanced Risk Management Through SDLC And GAMP®5 Techniques.
- Explore Future Cybersecurity Trends And Innovative Technologies Like AI.
- Build A Tailored Cybersecurity Response Plan Through Strategic Workshops.
Course Description
The stakes for medical device security and FDA compliance are higher than ever. Cyber threats continue to evolve, and staying ahead requires expertise in the latest regulations, technologies, and strategies.
This 6-hour intensive bootcamp is designed to equip professionals like you with the tools to address cybersecurity challenges and master the 2024 FDA regulatory landscape.
Why Attend?
-
- Navigate 2024 FDA Regulations with Confidence
Master the latest FDA guidelines and global standards like IEC 62304, with insights into recent updates that directly impact medical device cybersecurity. - Learn from Industry Leaders
Gain actionable insights from experts who specialize in medical device compliance and have firsthand experience tackling real-world cybersecurity threats. - Actionable Skills You Can Use Now
Through interactive case studies and hands-on exercises, learn how to build robust cybersecurity frameworks and maintain continuous FDA compliance. - Stay Future-Ready
Explore cutting-edge innovations shaping 2024 and beyond, including the impact of AI, blockchain, and other transformative technologies on medical device security.
- Navigate 2024 FDA Regulations with Confidence
By attending this bootcamp, you will:
-
- Gain a deep understanding of 2024’s FDA cybersecurity guidelines and their practical implementation.
- Acquire critical skills to identify vulnerabilities, mitigate risks, and protect sensitive device data.
- Build expertise that positions you as a leader in medical device compliance and cybersecurity.
- Stay ahead of emerging trends and threats reshaping the industry.
This program is perfect for professionals in medical device manufacturing, cybersecurity, compliance, and regulatory affairs who need actionable strategies for 2024 and beyond.
Empower your career and organization with the knowledge and tools to safeguard medical device data and stay ahead of evolving regulatory demands.
Enroll Now!
The stakes for medical device security and FDA compliance are higher than ever. Cyber threats continue to evolve, and staying ahead requires expertise in the latest regulations, technologies, and strategies.
This 6-hour intensive bootcamp is designed to equip professionals like you with the tools to address cybersecurity challenges and master the 2024 FDA regulatory landscape.
Why Attend?
-
- Navigate 2024 FDA Regulations with Confidence
Master the latest FDA guidelines and global standards like IEC 62304, with insights into recent updates that directly impact medical device cybersecurity. - Learn from Industry Leaders
Gain actionable insights from experts who specialize in medical device compliance and have firsthand experience tackling real-world cybersecurity threats. - Actionable Skills You Can Use Now
Through interactive case studies and hands-on exercises, learn how to build robust cybersecurity frameworks and maintain continuous FDA compliance. - Stay Future-Ready
Explore cutting-edge innovations shaping 2024 and beyond, including the impact of AI, blockchain, and other transformative technologies on medical device security.
- Navigate 2024 FDA Regulations with Confidence
By attending this bootcamp, you will:
-
- Gain a deep understanding of 2024’s FDA cybersecurity guidelines and their practical implementation.
- Acquire critical skills to identify vulnerabilities, mitigate risks, and protect sensitive device data.
- Build expertise that positions you as a leader in medical device compliance and cybersecurity.
- Stay ahead of emerging trends and threats reshaping the industry.
This program is perfect for professionals in medical device manufacturing, cybersecurity, compliance, and regulatory affairs who need actionable strategies for 2024 and beyond.
Empower your career and organization with the knowledge and tools to safeguard medical device data and stay ahead of evolving regulatory demands.
Enroll Now!
Why you should attend
In the rapidly evolving world of medical technology, keeping up with FDA’s latest cybersecurity mandates and safeguarding your devices against growing cyber threats is no longer optional—it’s essential.
This 6-hour intensive bootcamp will equip you with the tools, knowledge, and confidence to navigate the complexities of 2024 FDA updates while addressing the most pressing challenges in medical device security.
What Makes This Bootcamp Essential?
-
- Stay Ahead of Cyber Threats
As medical devices become increasingly connected, they face new vulnerabilities. This training offers actionable strategies to identify and mitigate risks, protecting your devices and patient data. - Master FDA Compliance Updates
Missing out on evolving FDA regulatory requirements can have serious consequences. Our bootcamp ensures you understand and implement 2024’s latest guidelines, avoiding compliance gaps. - Gain Hands-On Expertise
Through interactive discussions, case studies, and scenario-based learning, bridge the gap between theory and practice. Learn to apply advanced techniques in cybersecurity and risk management to real-world challenges.
- Stay Ahead of Cyber Threats
How Will This Training Benefit You?
-
- Enhance Your Skills
Develop advanced, job-ready skills in cybersecurity frameworks and regulatory compliance that are immediately applicable to your work. - Reduce Risks and Avoid Breaches
Learn to spot vulnerabilities early, implement stronger safeguards, and ensure continuous compliance to prevent costly breaches and failures. - Become a Leader in Cybersecurity
Position yourself as a trusted expert within your organization by taking a proactive stance on medical device security and compliance. - Invest in Career Advancement
Beyond meeting compliance standards, this bootcamp empowers you to lead initiatives that protect patient safety and secure organizational integrity.
- Enhance Your Skills
With cyber threats escalating and regulations evolving, there’s no better time to invest in your expertise. This training is designed to help you address immediate challenges, prepare for future threats, and stand out as a leader in this critical field.
Don’t miss this opportunity to transform your approach to medical device cybersecurity and FDA compliance.
Secure your spot today!
In the rapidly evolving world of medical technology, keeping up with FDA’s latest cybersecurity mandates and safeguarding your devices against growing cyber threats is no longer optional—it’s essential.
This 6-hour intensive bootcamp will equip you with the tools, knowledge, and confidence to navigate the complexities of 2024 FDA updates while addressing the most pressing challenges in medical device security.
What Makes This Bootcamp Essential?
-
- Stay Ahead of Cyber Threats
As medical devices become increasingly connected, they face new vulnerabilities. This training offers actionable strategies to identify and mitigate risks, protecting your devices and patient data. - Master FDA Compliance Updates
Missing out on evolving FDA regulatory requirements can have serious consequences. Our bootcamp ensures you understand and implement 2024’s latest guidelines, avoiding compliance gaps. - Gain Hands-On Expertise
Through interactive discussions, case studies, and scenario-based learning, bridge the gap between theory and practice. Learn to apply advanced techniques in cybersecurity and risk management to real-world challenges.
- Stay Ahead of Cyber Threats
How Will This Training Benefit You?
-
- Enhance Your Skills
Develop advanced, job-ready skills in cybersecurity frameworks and regulatory compliance that are immediately applicable to your work. - Reduce Risks and Avoid Breaches
Learn to spot vulnerabilities early, implement stronger safeguards, and ensure continuous compliance to prevent costly breaches and failures. - Become a Leader in Cybersecurity
Position yourself as a trusted expert within your organization by taking a proactive stance on medical device security and compliance. - Invest in Career Advancement
Beyond meeting compliance standards, this bootcamp empowers you to lead initiatives that protect patient safety and secure organizational integrity.
- Enhance Your Skills
With cyber threats escalating and regulations evolving, there’s no better time to invest in your expertise. This training is designed to help you address immediate challenges, prepare for future threats, and stand out as a leader in this critical field.
Don’t miss this opportunity to transform your approach to medical device cybersecurity and FDA compliance.
Secure your spot today!
Areas Covered
Session 1: Introduction and Foundation of Medical Device Cybersecurity (1.5 Hours)
-
- Overview of Software in Medical Devices: Explore the types, uses, and recent FDA focus areas for medical device software.
- Regulatory Landscape: Understand the key guidance documents and recent FDA findings impacting medical device cybersecurity.
- Introduction to IEC 62304: Learn how this standard plays a pivotal role in ensuring cybersecurity in medical devices.
Session 2: Compliance Framework and Quality Assurance (1.5 Hours)
-
- FDA Guidance on Medical Device Cybersecurity: Gain a clear understanding of FDA recommendations and other regulatory frameworks for compliance.
- Developing an SQA Plan: Learn how to create and implement a Software Quality Assurance (SQA) plan that aligns with regulatory requirements.
- Preparing for FDA Oversight: Discover what to expect during FDA inspections and how to prepare effectively for regulatory audits.
Session 3: System Integrity and Advanced Compliance Strategies (1.5 Hours)
-
- Ensuring System and Data Integrity: Understand the importance of GxP systems and Computer System Validation (CSV) for medical devices.
- Advanced Validation and Risk Management: Dive into SDLC methodologies and the application of GAMP®5 Software Categorization for enhanced compliance.
- System Risk Assessment: Master the tools and techniques for performing effective system risk assessments to mitigate vulnerabilities.
Session 4: Looking Ahead and Strategic Planning (1.5 Hours)
-
- Future Trends and Emerging Technologies: Examine how innovations like AI, blockchain, and other technologies are transforming medical device cybersecurity.
- Case Study on Cybersecurity Innovation: Analyze real-world examples of cutting-edge approaches to device security.
- Strategic Workshop: Develop a cybersecurity response strategy tailored to your organization’s needs.
- Comprehensive Recap and Q&A: Review key concepts and address outstanding questions to ensure clarity and readiness.
Customized Training Options
Looking for a version of this training tailored to your team’s needs? We offer customized sessions that focus on your specific areas of interest. These can be delivered online or in-person, depending on your schedule.
Contact us at support@compliancemeet.com to explore your options!
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
Session 1: Introduction and Foundation of Medical Device Cybersecurity (1.5 Hours)
-
- Overview of Software in Medical Devices: Explore the types, uses, and recent FDA focus areas for medical device software.
- Regulatory Landscape: Understand the key guidance documents and recent FDA findings impacting medical device cybersecurity.
- Introduction to IEC 62304: Learn how this standard plays a pivotal role in ensuring cybersecurity in medical devices.
Session 2: Compliance Framework and Quality Assurance (1.5 Hours)
-
- FDA Guidance on Medical Device Cybersecurity: Gain a clear understanding of FDA recommendations and other regulatory frameworks for compliance.
- Developing an SQA Plan: Learn how to create and implement a Software Quality Assurance (SQA) plan that aligns with regulatory requirements.
- Preparing for FDA Oversight: Discover what to expect during FDA inspections and how to prepare effectively for regulatory audits.
Session 3: System Integrity and Advanced Compliance Strategies (1.5 Hours)
-
- Ensuring System and Data Integrity: Understand the importance of GxP systems and Computer System Validation (CSV) for medical devices.
- Advanced Validation and Risk Management: Dive into SDLC methodologies and the application of GAMP®5 Software Categorization for enhanced compliance.
- System Risk Assessment: Master the tools and techniques for performing effective system risk assessments to mitigate vulnerabilities.
Session 4: Looking Ahead and Strategic Planning (1.5 Hours)
-
- Future Trends and Emerging Technologies: Examine how innovations like AI, blockchain, and other technologies are transforming medical device cybersecurity.
- Case Study on Cybersecurity Innovation: Analyze real-world examples of cutting-edge approaches to device security.
- Strategic Workshop: Develop a cybersecurity response strategy tailored to your organization’s needs.
- Comprehensive Recap and Q&A: Review key concepts and address outstanding questions to ensure clarity and readiness.
Customized Training Options
Looking for a version of this training tailored to your team’s needs? We offer customized sessions that focus on your specific areas of interest. These can be delivered online or in-person, depending on your schedule.
Contact us at support@compliancemeet.com to explore your options!
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!
-
- Cybersecurity Leaders Seeking Solutions to Mitigate Risks and Strengthen Defenses
- Regulatory Professionals Striving to Stay Ahead of FDA Compliance Updates
- Quality Assurance Managers Focused on Developing Effective SQA Plans
- Medical Device Developers Looking to Build Secure, Compliant Products
- IT Security Specialists Managing Data Integrity and Reducing Vulnerabilities
- Training Managers Designing Learning Paths for Cybersecurity and Compliance Teams
- HR Professionals Enhancing Workforce Skills to Address Cybersecurity Challenges
- Team Leaders Ensuring Their Group Meets Regulatory and Security Standards
- Compliance Officers Preparing for FDA Audits and Regulatory Inspections
Maximize The Learning Experience in A Group Setting!
-
- Cybersecurity Leaders Seeking Solutions to Mitigate Risks and Strengthen Defenses
- Regulatory Professionals Striving to Stay Ahead of FDA Compliance Updates
- Quality Assurance Managers Focused on Developing Effective SQA Plans
- Medical Device Developers Looking to Build Secure, Compliant Products
- IT Security Specialists Managing Data Integrity and Reducing Vulnerabilities
- Training Managers Designing Learning Paths for Cybersecurity and Compliance Teams
- HR Professionals Enhancing Workforce Skills to Address Cybersecurity Challenges
- Team Leaders Ensuring Their Group Meets Regulatory and Security Standards
- Compliance Officers Preparing for FDA Audits and Regulatory Inspections
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.
