4th Annual ComplianceOnline Medical Device Summit 2018 (COM)

When
Thu Jun 7
Where
Omni San Francisco Hotel
Time
08:00 AM
Tags
City
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Description


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






Find out who had attended the Medical Device Summit 2015 and 2016 by completing the short form below.






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 01 JUNE 07, 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





Track A - Sessions
Track B - Sessions


1:50 - 2:30 pm


The EU Regulations - Prepare for Implementation


Human Factors Compliance: Just Another “Hoop” or Good Business?




2:35 - 3:00 pm


Digital Health & Medical Devices


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



DAY 02 JUNE 08, 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





Track A - Sessions
Track B - Sessions


1:50 - 2:30 pm


The EU Regulations - Prepare for Implementation


Human Factors Compliance: Just Another “Hoop” or Good Business?




2:35 - 3:00 pm


Digital Health & Medical Devices


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

PAST SPEAKERS





Robin NewmanDirector, Office of Compliance, Center for Devices and Radiological Health, FDA
Robin Newman is the Director for the Office of Compliance at FDA’s Center for Devices and Radiological Health. Dr. Newman has 25+ years of senior level clinical/regulatory and compliance management experience in new product research and development. She’s served as a senior level executive and consultant for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system management and compliance, medical and technical writing, customer/patient interface and education, and management of Data Safety Monitoring Boards. Prior to joining FDA, Dr. Newman served as the Vice President of Quality Management for Siemens Healthcare Diagnostics, where she managed a multidisciplinary quality management and regulatory team and functioned as the primary representative for AdvaMedDx and the Diagnostic Tests Working Group. She holds a B.S. and M.S. in Nursing from the University of Texas, an Ed.D. from The George Washington University’s Executive Leadership Program, and holds certifications as a Pediatric Nurse Practitioner, in regulatory affairs (RAPS), and as a CCRA (ACRP).







Adam Saltman, MD PhDMedical Officer, CDRH/Office of Compliance
Adam E Saltman MD PhD is a Medical Officer in the Office of Compliance, Center for Devices and Radiological Health, at the Food and Drug Administration. He has worked with the FDA in both the premarket and postmarket arenas as a clinical reviewer since 2008. His primary responsibilities there now focus on the compliance medical device removal and correction process, as well as incorporating clinical benefit risk evaluations in recall and potential recall situations. Dr. Saltman consults regularly on clinical risk evaluations, device recall classifications, and public-facing FDA and manufacturer communications. Dr. Saltman left his clinical practice in cardiothoracic surgery in 2016, during which he held a special interest and key opinion leadership in the surgical treatment of atrial fibrillation. He has published more than 100 peer-reviewed articles, served on several journal editorial boards, and conducted competitively funded research projects. Dr. Saltman also holds an appointment of Clinical Associate Professor of Surgery at the Ohio University Heritage College of Osteopathic Medicine, where he teaches residents and medical students. He received his MD and his PhD degrees from Columbia University, his MS in health informatics from the University of Illinois at Chicago, and is certified as a Quality Improvement Associate by the American Society for Quality.







Ronny BrownBranch Chief for Medical Device Recalls, FDA








Stephen Allan WeitzmanEditor in Chief, FDA Information Repository, IRAI
Stephen Weitzman has been involved in healthcare matters for the past 45 years as a practicing lawyer and science consultant in the pharmaceutical, medical device, and food industries. He is a pioneer of the use of computers in legal and science research and litigations support systems from mainframe to personal computers. In the early 70’s he set up complex litigations support systems for fortune 100 corporations and their associations in the FTC nutrition advertising proceeding. Those systems blended data from exhibits, attorney files, science literature, surveys, and court decisions, including text and image files. He worked with Brower Murphy who created the first CD-ROM for data on a Toshiba music disc player, the Library of Congress Catalog as Library Corporation. Steve created the first CD-ROM on a government agency (FDA) in 1984, including internal FDA documents and manuals relating to training drug reviewers to enforcement manuals. He also built the FDA’s original website section on regulation enforcement.
In recent years he has also been involved in prosecuting major civil fraud litigation and patent infringement. The fraud litigation involved drug diversion and potential counterfeiting. The patent matters relate to information technology systems.
Currently focuses on the Medical Informatics for healthcare issues related to establishing a functional national health information infrastructure for sharing medical records for research, safety surveillance, and personalized medicine.







Casper E UldriksFormer Associate Center Director, FDA, CDRH
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.







Rita HoffmanRAC, Managing Partner, Regs & Recall Strategies, Former Branch Chief, Recalls, CDRH, FDA
Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.
Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.







Daniel L. AisenQuality Assurance. Regulatory Compliance, Proven Leadership, Former FDA Field Investigator and Former Public Health Inspector Naval Chief Hospital








Pat BairdRegulatory Head of Global Software Standards, Philips




Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for: - Discounts for multiple participants.- Require a price quotation.- Require to pay by wire transfer or PayPal- Invitation letter for visa applicationsNO REFUNDS ALLOWED ON REGISTRATIONS -----------------------------------------------------------------This Event is Brought to You by: METRICSTREAM INC - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.comMYL171013CEV








Location

location
  1. Omni San Francisco Hotel 500 California St, San Francisco, CA