5th Annual ComplianceOnline Medical Device Summit 2020

5th Annual Compliance Online Medical Device Summit 2020 About this Event *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Key Attraction INOVATIVE novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations. PLAN for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections. BUILD FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system. INTERACT with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities. DELIBERATE the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process. SCALE factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs' better understand the criteria's for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses. ENHANCE risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system. Why you should attend this summit Future Trends of Medical Device Regulation, Risk Management, UDI, Recall Complaint Management etc. Listen from FDA/CDRH Directors: What is Critical to Quality Get Update on FDA compliance Listen from FBI: Cyber Security Risks Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion Explore Upcoming Changes in Medical Devices under Trump Administration Change Management Criteria for Supplier Quality Agreement Establishing a Medical Device Security Program Panel Discussion FDA Warning Letter FDA Enforcement FDA Interaction Who Will Benefit? Quality Assurance/Quality Control Manufacturing and Contracting Supply Chain Management Import/Export Sales, Marketing and Business Development IT and Software Risk Management and Product Lifecycle Management Executive Management Regulatory Affairs Research and Development Engineers Scientists Documentation Compliance Officers Clinical/Lab Consultants/Service Providers/Suppliers AGENDA DAY 1 - APRIL 09, 2020 8:00 - 8:30 AM Registrations and Networking Breakfast 8:30 - 8:45 AM Welcome Speech with an Introduction of ComplianceOnline & Summit 8:45 - 9:10 AM Current Healthcare Eco System: Challanges & Opportunities - Keynote 9:15 - 9:45 AM Vendor Qualification and Selection - Panel Discussion 9:45 - 10:35 AM Change Management and Change Control 10:35 - 10:45 AM Networking Break 10:45 - 11:20 AM Regulations in the U.S. and Globally (GDPR, Brexit, US-China Relationship) 11:25 - 12:00 PM Medical Device Outsourcing, Supply Chains, Trade, Import/Export 12:00 - 1:00 PM Lunch 1:00 - 1:35 PM FDA Communication Power Tools - Panel Discussion 1:40 - 2:30 PM Cybersecurity, Robotics, AI, Machine Learning, & Iot/IIoT 2:30 - 2:45 PM Networking Break Track A - Sessions Track B - Sessions 2:45 - 3:15 PM 3D Printing MDR, IVDR 3:25 - 3:50 PM Wearable Device EU MDD, MDSAP 4:00 - 4:40 PM Sterilization of Medical Devices - Workshop 4:40 - 4:50 PM Closing Mark - Next Day Plan DAY 2 - APRIL 10, 2020 8:00 - 8:30 AM Registration and Networking Breakfast 8:30 - 9:00 AM Startups and $B Club - Keynote Speech 9:05 - 9:35 AM REACH and RoHS and Enviormnetal Compliance in FDA Regulated Industries 9:40 - 10:20 AM Medical Device Marketing and Advertisement, Social Media 10:20 - 10:35 AM Networking Break 10:35 - 11:10 AM Emerging Technologies of the Digital Health - Panel Discussion 11:15 - 11:40 AM Medical Device TPLC (Total Product Life Cycle) 11:45 - 12:15 PM 21st Century CURES Act and ISO 62304:2016 12:15 - 1:15 PM Lunch 1:15 - 1:50 PM Quality Challanges and Risk Management (ISO 13485 and ISO 14971) - Panel Discussion Track A - Sessions Track B - Sessions 1:50 - 2:20 PM FDA Compliance for SaaS/Cloud Environments Product Development: Engineering to Production 2:20 - 2:50 PM Techincal Writing and Documentation Premarket, postmarket and Recall 2:50 - 3:00 PM Networking Break 3:00 - 3:30 PM Wearable Devices 3:30 - 3:50 PM FDA Inspection and Meeting 3:50 - 4:15 PM ISO 10993 and Biocompatibility - Workshop 4:15 - 4:35 PM Vote of Thanks & Participation Certificate Distribution PAST SUMMIT SPEAKERS Lifei Liu, PhD, RAC Associate Director, Regulatory Affairs at Abbott Darin S. Oppenheimer, DRSc, RAC, FRAPS Executive Director, Head Drug Device Center of Excellence, Merck Matt Matuszewski Director Operations, Johnson and Johnson Peter Pitts Chief Regulatory Officer, Adherent Health, LLC. Kwame Ulmer Medical Device Executive | Angel Investor, Principal, Ulmer Ventures Tim Henning Co-Host of, HealthReform 2.0 Show and Podcast Thomas Loker Businessman | Author | Speaker, Startup Consultant and Advisor, SYDK.ORG Nick Sikorski,CISSP Manager, Deloitte & Touche LLP Robert Mai Senior Manager, Deloitte & Touche LLP Michael A Swit Principal, Law Offices of Michael A. Swit Catherine Casab MS Business Management, Quality Assurance Director, Third Pole Therapeutics Vesna Janic Director of Quality/Regulatory, StarFish Medical and ViVitro Labs Inc. Vee Arya Quality Director, Cannon Quality Group Mike Colvin Medical Device Consultant/Advisor, Syntilla Medical LLC Brian Shoemaker Principal Consultant, ShoeBar Associates Syed H. Askari PhD President, Medical Device Biopolymer LLC Virginia A. Lang, PhD President & Chief Scientist, HirLan, Inc. James Barley President, Ambired Consulting Services Darin S. Oppenheimer, DRSc, RAC, FRAPS Executive Director, Head Drug Device Center of Excellence, Merck Terri Jollymour (Sr. Director, Operations Readiness & Convergence Johnson & Johnson Corporate Supply Chain Quality & Compliance) Pat Baird Regulatory Head of Global Software Standards, Philips Tom Loker (Businessman | Author | Speaker, Startup Consultant and Advisor SYDK.ORG, Contributor to California Political Review) Dr. Ron Weissman (Chairman, Software SIG, Band of Angels) Stan Mastrangelo Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards, Professor, Center for Applied Health Sciences, Virginia Tech University Daphne Walmer Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications Michael Weickert Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business