5th Annual ComplianceOnline Medical Device Summit 2020

5th Annual Compliance Online Medical Device Summit 2020
About this Event
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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