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Who should attend 4th Annual ComplianceOnline Medical Device Summit 2018
Quality Assurance/Quality Control, Manufacturing and Contracting, Supply Chain Management, Import/ExportSales, Marketing and Business Development, IT and Software, Risk Management and Product Lifecycle Management, Executive Management, Regulatory Affairs
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4th Annual ComplianceOnline Medical Device Summit 2018  

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Seminar Summary:

Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion and Explore Upcoming Changes in Medical Devices under Trump Administration. (see full course description)

 
 

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Training Course Syllabus:


Key Attraction

Innovate 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 criterias 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

Day 1 June 7, 2018

  • 8:00 - 8:30 am : Registration and Breakfast
  • 8:30 - 8:45 am : Welcome Speech with an Introduction of ComplianceOnline & Summit
  • 8:45 - 9:10 am : Adequate Directions for Use "in the Age of AI and Watson"
  • 9:10 - 9:40 am : FDA Enforcement – Outlook &
  • 9:40 - 10:20 am : Implications - Panel Discussion Benefit-Risk: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
  • 10:20 - 10:40 am : Medical Devices under Trump Administration
  • 10:40 - 11:10 am : Change Management - Managing the Cost of Change
  • 11:10 - 11:25 am : Networking Break
  • 11:25 - 12:05 pm : Post-Market Compliance; No Easy Journey
  • 12:05 - 12:30 pm : Establishing a Medical Device Security Program
  • 12:30 - 1:30 pm : Lunch
  • 1:35 - 2:05 pm : Off-label Promotion: Truth or Consequences
  • 2:10 - 2:35 pm : Track A - Sessions : Medical Device Single Audit Program (MDSAP) - Can I Really Get Down to Just One Audit?
  • Track B - Sessions : Cleaning, Disinfection and Sterilization of Re-usable Medical Devices
  • 2:40 - 3:05 pm : Track A - Sessions : Documentation for Agile Development - Shared Understanding, Vacation Photos, and Compliance
  • Track B - Sessions : Is Your Medical Device Software Ready for a 510K?
  • 3:10 - 3:40 pm : Medical Device Risk Management 2017 Updates - Workshop
  • 3:40 - 3:55 pm : Networking Break
  • 3:55 - 4:25 pm : Best Practices When Interacting with FDA - Panel Discussion
  • 4:25 - 4:35 pm : Closing Mark - Next Day Plan
  • Day 2 June 8, 2018

  • 8:00 - 8:30 am : Registration and Breakfast
  • 8:30 - 9:00 am : Cyber Security Risks and Working with Law Enforcement - Keynote Speech
  • 9:00 - 9:30 am : Medical Devices and the Future of Outcomes Centricity - Keynote Speech
  • 9:30 - 10:00 am : Medical Device Enhancements - Keynote Speech
  • 10:00 - 10:25 am : Effective Internal Auditing for Superior Quality Systems
  • 10:25 - 10:55 am : CDRH Office of Compliance Strategic Priorities and Hot Topics in Compliance - Keynote Speech
  • 10:55 - 11:10 am : Networking Break
  • 11:10 - 11:40 am : FDA Upcoming Electronic Submission Process
  • 11:40 - 12:15 pm : Is a Quality Agreement Required for All Suppliers? - Panel Discussion
  • 12:15 - 12:45 pm : Global Regulatory Landscape (US, EU and APAC): What’s on the Horizon?
  • 12:45 - 1:45 pm : Lunch
  • 1:50 - 2:30 pm : Track A - Sessions : The EU Regulations - Prepare for Implementation
  • Track B - Sessions : Human Factors Compliance: Just Another “Hoop” or Good Business?
  • 2:35 - 3:00 pm : Track A - Sessions : Digital Health & Medical Devices
  • Track B - Sessions : Practical Lessons from 16 years of the Agile Community
  • 3:00 - 3:15 pm : Networking Break
  • 3:15 - 3:40 pm : Learning From FDA Warning Letter - How to Stay Out of Trouble? - Keynote Speech
  • 3:40 - 4:00 pm : Vote of Thanks & Participation Certificate Distribution
  • Seminar Summary:

    Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion and Explore Upcoming Changes in Medical Devices under Trump Administration. (see full course description)

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