Location:
Courtyard Chicago Downtown/River North
30 E Hubbard St, Chicago, IL 60611
AGENDA
Day 1
| Time | Session Title | Speaker | Session Description |
|---|---|---|---|
| 12:00 – 1:00 PM | Registration – Coffee & Tea | ||
| 1:00 – 1:15 PM | Chairperson’s Opening Remarks | ||
| 1:15 – 2:15 PM | Digitalization: Future Challenges & Opportunities in the Medical Device Industry | Moderator: Khaled Moussally, Executive Vice President, Corporate Development & Operations, Compliance Group Panelists: Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic Xenophon Papademetris, Professor, Yale School of Medicine Kalpesh Patel, Associate Director QA, BeiGene Steve Silverman, President, The Silverman Group |
|
| 2:15 – 3:00 PM | Global Regulations & Medical Devices: Ensuring Compliance in the Medical Device Industry | Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine | |
| 3:00 – 3:30 PM | Networking Refreshment Break and Exhibit Showroom | ||
| 3:30 – 4:00 PM | FDA Compliance: Recent Updates & Essential Guidelines for Medical Device Manufacturers | Rafael Padilla, Compliance Officer, FDA, ORA
Janet Pulver, MS, CMQ/OE, CSSGB, CQA, RAC, CTBS, Medical Device Senior Operations Officer, FDA, Office of Medical Device and Radiological Health Operations |
|
| 4:00 – 4:30 PM | Cybersecurity for AI Medical Devices | Pat Baird, Sr. Regulatory Specialist, Philips | Topics: • What makes AI/ML different than traditional software? • Example cybersecurity incidents related to AI/ML products • Current standards & whitepaper landscape • Detailed walkthrough for CTA and AAMI standards projects Takeaway Tools: |
| 4:30 – 5:00 PM | Supply Chain Management and Outsourcing in Medical Device Manufacturing | Luiz Barberini, External Manufacturing Operations Manager LATAM Head, Bayer | Topics: How Bayer’s external relationship governance model adds value to the medical devices and radiology business ensuring a reliable and lean partnership • A snapshot on logistics roadblocks that affects distribution – a benchmarking between US and Brazil infrastructure • How Bayer stablished a trustful relationship with CMO/CTS/3PLs/MDS to guarantee a reliable compliant trustful supply • Tips on how to improve your relationship with suppliers |
| 5:00 PM | Networking Cocktail Reception |
Day 2
| Time | Session Title | Speaker | Session Description |
|---|---|---|---|
| 8:00 – 9:00 AM | Exhibitor Showroom Opens and Lite Breakfast | ||
| 9:10 – 10:10 AM | Select Between Knowledge Exchange Sessions | ||
| 9:10 – 10:10 AM | Best Practice in Regulatory Writing of Devices (Medical Devices (MD) & Invitro Diagnostic Devices (IVD): Common Pitfalls | Dr. Radhika Ramachandran, Head of Medical Regulatory Writing, Freyr Inc. | Topics: • Introduction to regulatory writing • Regulatory landscape • Common pitfalls in regulatory writing • Impact of pitfalls on regulatory submissions • Best practices to avoid pitfalls • Case studies/examples Takeaway Tools: |
| 9:10 – 10:10 AM | How AI and Machine Learning are Revolutionizing Medical Software: An Overview | Xenophon Papademetris, Professor Yale School of Medicine | Topics: • Acquire a basic understanding of the history of AI and the different types of technologies that come under this umbrella • Understand the relationship and differences between traditional software engineering and machine learning-generated components. • Understand the challenges in the development and testing of AI/ML Components • Understand the use of AI tools in the creation of software Takeaway Tools: |
| 10:20 – 11:00 AM | Select Between Knowledge Exchange Sessions | ||
| 10:20 – 11:00 AM | Panel Discussion: SupplierAudits | Moderator: Ravi Nabar, Senior Vice President, Quality and Regulatory Compliance, Compliance Group
Panelists: Rafael Padilla, Compliance Officer, FDA, ORA Janet Pulver, MS, CMQ/OE, CSSGB, CQA, RAC, CTBS, Medical Device Senior Operations Officer, FDA, Office of Medical Device and Radiological Health Operations |
|
| 10:20 – 11:00 AM | Change Control During Post Approval | Ritam Priya, Consultant Novarum, MDRQ Consulting | Topics: • What is change control • Change control standards and regulations • Classification of change • Controlling and managing change o Hardware based medical devices o Software as medical device (including AI/ML based medical devices) • Communication of changes • Documenting change control procedure • Managing supplier changes • Change control challenges • Other |
| 11:00 – 11:30 AM | Exhibitor Showroom and Refreshment Break | ||
| 11:30 – 12:10 PM | Select Between Knowledge Exchange Sessions | ||
| 11:30 – 12:10 PM | Innovation, Do You REALLY Know Your Fastest Path to Market? | Stephen Tyrpak, VP of North America, Partner, Principal Consultant, PQE Group | |
| 11:30 – 12:10 PM | Data Management & the Cloud: Tips & Tricks for Success | Lacey Harbour, RAPS, MB(ASCP) CM, Regulatory Affairs Manager Thermo Fisher Scientific | Topics: • The importance of a data management strategy that aligns with the responsible corporate culture • Data governance and change control considerations • Supplier or purchasing controls for your cloud supplier • Discussion of data security requirements • Considerations for data sharing agreements with deployed products at customers sites that can impact the evolution of your product • Real world monitoring of deployed products Takeaway Tools: |
| 12:10 – 1:10 PM | Lunch and Learn | ||
| 12:10 – 1:10 PM | Ask the FDA Your Regulatory Questions for the Medical Device Industry | Rafael Padilla, Compliance Officer FDA, ORA
Janet Pulver, MS, CMQ/OE, CSSGB, CQA, RAC, CTBS, Medical Device Senior Operations Officer FDA, Office of Medical Device and Radiological Health Operations |
|
| 1:10 – 1:50 PM | Select Between Knowledge Exchange Sessions | ||
| 1:10 – 1:50 PM | Avoiding Pitfalls in AI/ML Medical Device Premarket Applications | Donna-Bea Tillman, Ph.D, FRAPS, Senior Consultant Biologics Consulting | Topics: • Understand the regulatory framework for medical device premarket submissions • Appreciate the unique regulatory challenges associated with software as a medical device that uses AI/ML • Explore the potential pitfalls commonly encountered in AI/ML premarket submissions • Develop an understanding what you can do to avoid the pitfalls • Become aware of the new regulatory programs that FDA is developing in this area Takeaway Tools: |
| 1:10 – 1:50 PM | Supplier QualityAgreements | Ravi Nabar, Senior Vice President, Quality and Regulatory Compliance Compliance Group; Steve Silverman, President, The Silverman Group | |
| 2:00 – 3:00 PM | Speed Networking & Training | ||
| 3:10 – 3:50 PM | Select Between Knowledge Exchange Sessions | ||
| 3:10 – 3:50 PM | Know Your Enemy: Why Constant Evaluation of Your Process’s Unique and Transient Microflora Is Necessary for Consistent Release of Sterile Devices | Anthony Grilli, CEO & Owner, FOCUS Laboratories | |
| 3:10 – 3:50 PM | Ethical Considerations in AI-Driven Medical Devices: Innovation with Patient Privacy and Safety | Lacey Harbour, RAPS, MB(ASCP) CM, Regulatory Affairs Manager, Thermo Fisher Scientific | Topics: • The importance of developing a company culture that supports responsible and transparent AI enabled healthcare products • A suggested policy and SOP infrastructure to support responsible and transparent development • The market value to responsible AI • A better understanding of “bias” • An understanding of data consent and how that might impact developers • Understanding of the US federal government’s current requirements around the AI healthcare products ecosystem Takeaway Tools: • Corporate policy infrastructure for AI enablement • Resource list of powerful federal tools |
| 4:00 – 5:00 PM | Vendor Audits: Best Practices for Compliance and Quality Assurance in Manufacturing | Kelly Menze, Senior Global Supplier Quality Engineer, Creation Technologies
Andrea Roether, Senior Director of Global Quality, Creation Technologies |
Topics: • Assessing Risk – What potential risk does the vendor pose to the organization? o Tools: risk matrix • Audit Strategy – How does the vendor audit support the organizational goals? o Tools: support request form • Planning for vendor audit – two-way communication to facilitate an efficient and collaborative vendor audit o Tools: audit agenda, audit forms • Executing the vendor audit – use of standard best practices to achieve the best results o Tools: ISO 19011 audit guidelines • Closing the vendor audit – providing clear feedback and next steps o Tools: audit report, SCAR/8D • Sustainability or impact – contributing to the vendor’s continuous improvement journey and verifying the intended outcome o Tools: performance monitoring |
| 4:00 – 5:00 PM | Verification & Testing Strategies for Compliance | Joanne Goldberg, Sr. Principal Business Analyst, Medtronic |
Topics:
• Review typical testing pitfalls
• Identify key components of successful testing strategies
• Learn how to implement changes in your organization
• Improve the effectiveness of your testing program
• Ensure successful outcome of compliance audits
|
Day 3
| Date and Time | Session Title | Speaker | Description |
|---|---|---|---|
| 8:00 – 9:00 AM | Exhibitor Showroom Opens and Lite Breakfast | ||
| 9:10 – 9:50 AM | Select Between Knowledge Exchange Sessions | ||
| 9:10 – 9:50 AM | Proactive Monitoring and Control for Safety and Compliance | Yowvanaraj Gopal, Director – Professional Services, ValGenesis Inc. | Getting a medical device to market is a significant milestone in the lifecycle of the device where the critical aspects and focus went through in the design, develop, test and manufacturing of the device. Establishing a proactive monitoring program by integrating all the sources of information by leveraging the technology, resources and processes will assure that the initial efforts are consistently delivering the benefit, safety and improving the patient quality of life, improves the end-to-end process and lead to innovate for the future. Disconnected and silo of information is not bringing all the critical aspects for effective consumption of the data and assess the impact in all possible areas to improve the safety and usage. Integrating the data sources and leveraging the technological advancements provides greater insights and improves the patient’s safety and overall compliance. |
| 9:10 – 9:50 AM | Validation Strategies for AI-Powered Medical Devices for Accuracy and Reliability | Kalpesh Patel, Associate Director QA BeiGene | Topics: • Introduction to GxP • AI in medical devices • Importance of CSV with AI based medical device compliance. • Challenges in validating AI systems • Validation strategies with risk-based approach. • Case studies • Best practices and future trends |
| 10:00 – 10:40 AM | Select Between Knowledge Exchange Sessions | ||
| 10:00 – 10:40 AM | Complaint Management Best Practices: Ensuring Regulatory Compliance The FDA’s Perspective | Rafael Padilla, Compliance Officer, FDA, ORA; Janet Pulver, MS, CMQ/OE, CSSGB, CQA, RAC, CTBS, Medical Device Senior Operations Officer, FDA, Office of Medical Device and Radiological Health Operations |
|
| 10:00 – 10:40 AM | Validating Using AI | Madhavi Ganesan, Life Sciences Solution Director, KPMG | |
| 10:40 – 11:10 AM | Exhibitor Showroom and Refreshment Break | ||
| 11:10 – 12:00 PM | Select Between Knowledge Exchange Sessions | ||
| 11:10 – 12:00 PM | Risk Management & Hazard Analysis in Medical Device Design | Rucha Patel, Manager of Quality & Regulatory Affairs, MIMOSA Diagnostics Inc. | Topics • Introduction to risk management in medical device design • Framework and processes for risk management • Identifying hazards in medical device design • Risk analysis techniques • Risk evaluation, mitigation, and acceptance • Residual risk management • ISO 14971:2019 vs FMEA: What is best for you? Takeaway Tools • Risk management flow chart • Example template of risk evaluation matrix and risk analysis file |
| 11:10 – 12:00 PM | New Developments in Cloud Environments | Pat Baird, Sr. Regulatory Specialist, Philips; Xenophon Papademetris, Professor, Yale School of Medicine |
Topics: • Understand the core challenge of using public cloud services in medical devices • Learn about the upcoming AAMI TIR describing best practices in this area • Explore the implications of some of this work in other aspects of medical software development • Learn about system of systems theory and its implications for medical software development and management Takeaway Tools: • Links to the consensus report AAMI CR 510 that is the foundation for this work • Resource page with listings of additional readings to better understand the challenges involved |
| 12:00 – 1:00 PM | Lunch and Learn
Ask the FDAYour Cybersecurity Questions |
Justin Post, OPEQ Cybersecurity Policy Analyst, FDA, CDRH (Invited) Jessica Wilkerson, Medical Device Cybersecurity Team Lead, FDA, CDRH | |
| 1:10 – 1:50 PM | Select Between Knowledge Exchange Sessions | ||
| 1:10 – 1:50 PM | Audit Ready: Strategies for Successful Regulatory Inspections and Audits | David W. Vincent MPH, Ph.D, Chief Scientific Officer VTI Life Sciences | |
| 1:10 – 1:50 PM | Real-World Evidence: Leveraging Data for Post-Approval Success | Taylor Dieringer, Staff Quality Engineer – Risk Management iRhythm Technologies, Inc. |
Topics:
• Discuss the critical role of post-market data and application to continuous improvement, regulatory submissions, and device iterations
• Learn strategies for integrating post-market data into regulatory submissions and post-market surveillance
• Discover how to effectively collect, analyze, and interpret post-market data to support product safety and efficacy
• Gain insights into the challenges and solutions for ensuring data quality and reliability in real-world evidence studies
• Acquire knowledge of the latest regulatory guidelines and expectations related to post-market data
Takeaway Tools:
• White paper on appropriate statistical techniques for data analysis
• Process workflow example for post-market data
|
| 2:00 – 3:00 PM | Select Between Knowledge Exchange Sessions | ||
| 2:00 – 3:00 PM | Human-Centered Design: Enhancing User Experience in Medical Devices | Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine | |
| 2:00 – 3:00 PM | Digital Diagnostics – Validating 3rd Party Software | Joanne Goldberg, Sr. Principal Business Analyst, Medtronic |
Topics:
• Understand the scope of your responsibilities
• Create a process for assessing risk
• Learn how to document your validation strategy
• Establish a change control approach
• Ensure success through a continuous improvement process
|
| 3:00 – 3:30 PM | Exhibitor Showroom and Refreshment Break | ||
| 3:30 – 4:10 PM | Select Between Knowledge Exchange Sessions | ||
| 3:30 – 4:10 PM | Cybersecurity & Data Privacy in Connected Medical Devices | Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group | In the rapidly evolving healthcare technology landscape, integrating connectivity into medical devices has revolutionized patient care, enabling real-time monitoring, personalized treatment, and improved health outcomes. However, this connectivity brings significant cybersecurity and data privacy challenges. This presentation explores the critical intersection of cybersecurity, safety, and privacy in connected medical devices. We will explore the multifaceted nature of these devices’ cyber threats, including vulnerabilities to hacking, unauthorized access, and data breaches, which can compromise patient safety and the confidentiality of sensitive health information. The discussion will highlight the importance of treating safety and privacy risks as integral components of cybersecurity threat modeling. Attendees will gain insights into: • The intersection of cybersecurity and patient safety in connected medical devices • Effective methodologies for identifying, analyzing, and mitigating cyber threats • Best practices for ensuring data privacy and compliance with global regulatory frameworks • The importance of continuous monitoring and updating of security measures to adapt to evolving threats This presentation will provide valuable insights into the challenges and strategies for safeguarding connected medical devices against cyber threats while ensuring patient safety and data privacy. |
| 3:30 – 4:10 PM | Ensuring Compliance & Patient Safety Post-Market | Taylor Dieringer, Staff Quality Engineer – Risk Management iRhythm Technologies, Inc. | Topics: • Discuss the incorporation of risk-based approaches and how it applies to different aspects of the quality management system • High-level overview of ISO 14971 and its application in post-market risk management • Learn how to effectively implement a risk management process that ensures patient safety and regulatory compliance • Understand the importance of continuous monitoring and updating the risk management file to address emerging risks • Examine case studies that highlight successful risk management strategies and common pitfalls to avoid Takeaway Tools: • Risk trending guidance in the medical device industry • Process workflow example for handling data with potential patient impact |
| 4:20 – 5:00 PM | Select Between Knowledge Exchange Sessions | ||
| 4:20 – 5:00 PM | Case Study: Design Control for Medical Devices | Rucha Patel, Manager of Quality & Regulatory Affairs MIMOSA Diagnostics Inc. | |
| Medical Device Cybersecurity Panel Discussion: Strategies for Regulatory Compliance& Patient Safety | Moderator: Xenophon Papademetris, Professor, Yale School of Medicine Panelists: Kalpesh Patel, Associate Director QA, BeiGene |
Medical Device Validation & Verification University
Unlock the future of medical device validation and verification at Medical Device Validation & Verification University, a power-packed 3-day conference and training program. Stay at the forefront of industry trends and regulatory requirements with our comprehensive agenda covering Design & Development, Digitalization, Post Approval, and Compliance Intelligence across 4 dedicated tracks.
Led by top-tier industry & regulatory experts, dive into the latest knowledge, best practices, and real-world case studies that drive success in medical device validation and verification. Connect with peers, expand your network, and gain invaluable insights to elevate your professional journey.
Join us in Chicago, Illinois, from September 17-19, 2024, for an immersive experience filled with over 30+ sessions led by seasoned professionals. Secure your spot now and take advantage of early bird pricing until August 9, 2024. Don’t miss this opportunity to propel your career forward in the dynamic realm of medical device innovation!
Design & Development
- Innovation Case Study: From Concept to Prototype to Market
- Case Study: Design Control for Medical Devices
- Verification & Testing Strategies for Compliance
- Risk Management & Hazard Analysis in Medical Device Design
- Validation & Verification for Custom & Unique Devices
Post Approval
- Change Control During Post Approval
- Real-World Evidence: Leveraging Data for Post-Approval Success
- Recall Management 101: Best Practices for Safety & Compliance
- Labeling Changes: Strategies for Regulatory Compliance and Efficiency
- Ensuring Compliance & Patient Safety Post-Market
Compliance Intelligence
- Global Regulations & Medical Devices: Ensuring Compliance in the Medical Device Industry
- Medical Device Cybersecurity: Strategies for Regulatory Compliance and Patient Safety
- Vendor Audits: Best Practices for Compliance and Quality Assurance in Manufacturing
- FDA Compliance: Essential Guidelines for Medical Device Manufacturers
- Case Study: Overcoming Regulatory Challenges in Medical Device Industry
Digitalization
- Panel Discussion on Digitalization: Future Challenges & Opportunities in the Medical Device Industry
- Cybersecurity & Data Privacy in Connected Medical Devices
- Case Study: Implementing AI & Machine Learning in Med-Devices
- Data Management & the Cloud: Tips & Tricks for Success
- Ethical Considerations in AI-Driven Medical Devices: Innovation with Patient Privacy and Safety
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.
