2-Day Virtual Bootcamp on FDA Cybersecurity Protocols for Medical Devices: Ensuring Compliance and Safety
Mitigate Risks Using Advanced Technology To Prepare Your Team Against Modern Cybersecurity Threats!
Instructor :
Carolyn Troiano
Webinar ID:
10915
Date: APR 14 (MON) - APR 15 (TUE), 2025
Start Time: 9 AM PT - 1 PM PT each day
Duration: 8 Hrs.
What you will learn
-
- Introduction To Types And Vulnerabilities Of Medical Device Software.
- Detailed Review Of FDA Guidance And Relevant Regulations.
- Coverage Of IEC 62304 Compliance And Its Importance.
- Development And Implementation Of A Software Quality Assurance Plan.
- Insight Into FDA’s Pre-Certification Pilot Program For
-
- Introduction To Types And Vulnerabilities Of Medical Device Software.
- Detailed Review Of FDA Guidance And Relevant Regulations.
- Coverage Of IEC 62304 Compliance And Its Importance.
- Development And Implementation Of A Software Quality Assurance Plan.
- Insight Into FDA’s Pre-Certification Pilot Program For Digital Health.
- Preparation Strategies For FDA Regulatory Oversight And Inspections.
- Exploring System And Data Integrity Requirements In Medical Devices.
- Advanced CSV, SDLC Methodologies, And Risk Assessment Techniques.
- Future Trends In Cybersecurity And Strategic Closing Workshop
Course Description
Elevate Your Compliance and Cybersecurity Acumen with Our Premier 2-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 2-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.
Secure your spot now!
Elevate Your Compliance and Cybersecurity Acumen with Our Premier 2-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 2-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.
Secure your spot now!
Why you should attend
Adapt to an Evolving Landscape: The medical device industry is undergoing rapid evolution, driven by technological advancements and escalating cyber threats.
This bootcamp is crafted to help you stay ahead by deepening your understanding of how these changes affect FDA regulations and cybersecurity protocols.
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!
Adapt to an Evolving Landscape: The medical device industry is undergoing rapid evolution, driven by technological advancements and escalating cyber threats.
This bootcamp is crafted to help you stay ahead by deepening your understanding of how these changes affect FDA regulations and cybersecurity protocols.
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!
Areas Covered
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.
Day 1: Foundations of Medical Device Software and Compliance : 4-hrs
Module 1: Overview of Software in Medical Devices
- Introduction to Medical Device Software: Types and Uses
- Regulatory Landscape and FDA Focus (including recent guidance documents)
- Understanding Vulnerabilities and Challenges
- Recent FDA Findings and Case Studies
Module 2: Regulatory Framework and Compliance Standards
- Comprehensive Review of FDA Guidance on Medical Device Cybersecurity
- Other Relevant FDA Activities and Regulations
- Introduction to IEC 62304 and its role in medical device cybersecurity
Module 3: Software Quality Assurance (SQA) and Pre-Certification
- Developing and Implementing a Software Quality Assurance (SQA) Plan
- Overview and Impact of FDA’s Pre-Certification Pilot Program for Digital Health
- Best Practices as per Latest FDA Guidance
Module 4: Preparation for Oversight & Inspection
- FDA Regulatory Oversight & What to Expect During Inspections
- Preparing for Compliance: Steps and Checklist
- Discussion and Interactive Q&A
Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Day 2: Advanced Compliance Strategies and Looking Ahead: 4-hrs
Module 1: Ensuring System and Data Integrity
- Ensuring System and Data Integrity in Medical Devices
- Importance of GxP Systems and Their Relevance
- Introduction to Computer System Validation (CSV)
Module 2: Advanced Validation and Risk Management
- Detailed Exploration of System Development Life Cycle (SDLC) Methodologies
- Applying GAMP®5 Software Categorization
- System Risk Assessment: Tools and Techniques
Module 3: Future Trends and Emerging Technologies
- Regulatory Outlook and Upcoming Changes
- Anticipating Future Trends in Medical Device Cybersecurity
- Emerging Technologies and Their Implications for Compliance and Security
- Best Practices for Maintaining Cybersecurity Compliance
- Case Study: Innovative Approaches to Cybersecurity
Module 4: Recap and Strategic Discussions
- Comprehensive Recap of Key Points from Both Days
- Strategic Workshop: Creating a Cybersecurity Response Strategy
- Final Q&A and Closing Remarks
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.
Day 1: Foundations of Medical Device Software and Compliance : 4-hrs
Module 1: Overview of Software in Medical Devices
- Introduction to Medical Device Software: Types and Uses
- Regulatory Landscape and FDA Focus (including recent guidance documents)
- Understanding Vulnerabilities and Challenges
- Recent FDA Findings and Case Studies
Module 2: Regulatory Framework and Compliance Standards
- Comprehensive Review of FDA Guidance on Medical Device Cybersecurity
- Other Relevant FDA Activities and Regulations
- Introduction to IEC 62304 and its role in medical device cybersecurity
Module 3: Software Quality Assurance (SQA) and Pre-Certification
- Developing and Implementing a Software Quality Assurance (SQA) Plan
- Overview and Impact of FDA’s Pre-Certification Pilot Program for Digital Health
- Best Practices as per Latest FDA Guidance
Module 4: Preparation for Oversight & Inspection
- FDA Regulatory Oversight & What to Expect During Inspections
- Preparing for Compliance: Steps and Checklist
- Discussion and Interactive Q&A
Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Day 2: Advanced Compliance Strategies and Looking Ahead: 4-hrs
Module 1: Ensuring System and Data Integrity
- Ensuring System and Data Integrity in Medical Devices
- Importance of GxP Systems and Their Relevance
- Introduction to Computer System Validation (CSV)
Module 2: Advanced Validation and Risk Management
- Detailed Exploration of System Development Life Cycle (SDLC) Methodologies
- Applying GAMP®5 Software Categorization
- System Risk Assessment: Tools and Techniques
Module 3: Future Trends and Emerging Technologies
- Regulatory Outlook and Upcoming Changes
- Anticipating Future Trends in Medical Device Cybersecurity
- Emerging Technologies and Their Implications for Compliance and Security
- Best Practices for Maintaining Cybersecurity Compliance
- Case Study: Innovative Approaches to Cybersecurity
Module 4: Recap and Strategic Discussions
- Comprehensive Recap of Key Points from Both Days
- Strategic Workshop: Creating a Cybersecurity Response Strategy
- Final Q&A and Closing Remarks
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!
-
- Medical Device Quality Assurance Managers
- Regulatory Affairs Specialists
- Medical Device Compliance Officers
- Cybersecurity Analysts (Healthcare/MedTech)
- Product Safety Engineers (Medical Devices)
- Medical Device R&D Engineers
- Clinical Systems Engineers
- Medical Device Project Managers
- Healthcare IT Managers
- Biomedical Engineers
- Risk Management Specialists (Medical Devices)
- Chief Technology Officers (MedTech Companies)
Maximize The Learning Experience in A Group Setting!
-
- Medical Device Quality Assurance Managers
- Regulatory Affairs Specialists
- Medical Device Compliance Officers
- Cybersecurity Analysts (Healthcare/MedTech)
- Product Safety Engineers (Medical Devices)
- Medical Device R&D Engineers
- Clinical Systems Engineers
- Medical Device Project Managers
- Healthcare IT Managers
- Biomedical Engineers
- Risk Management Specialists (Medical Devices)
- Chief Technology Officers (MedTech Companies)
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.
