ComplianceOnline

Download Brochure

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.

2015 and 2016 SUMMIT SPEAKERS

Ron Brown

Branch Chief for Medical Device Recalls, FDA

Marisa White

Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH

Robin Newman

Director, Office of Compliance at Food & Drug Administration, CDRH

Seth D. Carmody, Ph.D

Cybersecurity Project Manager, CDRH

Bakul Patel

Associate Director for Digital Health at FDA

Chrissy Cochran

Acting Director, Division of Enforcement and Postmarketing Safety at FDA

Bill MacFarland

Director, Division of Enforcement B, Office of Compliance, FDA/CDRH

Erin Keith

Director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, CDRH, FDA

Cisco Vicenty

Acting-Branch Chief, Office of Compliance CDRH/FDA

Neil Mafnas

Assistant Regulator CDRH/FDA

Ann Ferriter

Director, Division of Analysis and Program Operations CDRH/OC at FDA

James Saviola

Deputy Director of Regulatory Affairs (Acting), and Director, Division of Biomedical Research, Office of Compliance, CDRH

Rick Williams

Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board Member of Amorphex Therapeutics

Peter Pitts

Chief Regulatory Officer, Adherent Health, LLC.

French Caldwell

Chief Evangelist, MetricStream

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

Rohit Bedi

Senior Vice President of Partnerships, MetricStream

Minda Wilson

Founder, Affordable Healthcare Review

Stan Mastrangelo

Professor, Center for Applied Health Sciences, Virginia Tech University

Fletcher Wilson

CEO and Founder, InterVene Inc.

Patrick Rousche

Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc.

David Nettleton

Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA, Software Validation, and Computer System Validation.

Brian Shoemaker, Ph.D.

Principal Consultant, ShoeBar Associates

Geetha Rao

CEO, Springborne Lifesciences

Keith Morel, Ph.D.

VP, Regulatory Compliance, Qserve Group US Inc.

Andrew Pfeifer, Ph.D.

Account Executive, REED TECH

Virginia A. Lang, Ph.D., Ph.D.

President & Chief Scientist, HirLan, Inc.

Angela Bazigos

CEO, Touch Stone Technologies Silicon Valley

Eduardo Cervantes

President & CEO Morf Media Inc.

Darin Oppenheimer

Regulatory Affairs Expert, Global Medical Device Regulations & Licensure Authority, Strategic & Engaging Leader, Baxter Healthcare Corporation.

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

Scott Phillips

President Starfish Medicals

Terri Jollymour

Sr. Director, Operations Readiness & Convergence Johnson & Johnson Corporate Supply Chain Quality & Compliance

Susan W. Neadle

Head, Combination Products Center of Excellence Sr. Director, Design to Value and Quality Engineering Janssen Supply Group

Haley Lentz

GUDID Submission Subject Matter Expert, Reed Tech

Gunjan Sinha

Executive Chairman, MetricStream

Mitch Levinson

Founder, President & CEO, Cerebrotech Medical Systems

Julia Rasooly

CEO, Puracath

Mark Mitchell

SVP Corporate Development at MetricStream & Business head ComplianceOnline

Joe Franchetti

FDA Regulatory Compliance Specialist, JAF Consulting Inc.

Kevin Fleming

National Healthcare Managing Director at Newport Board Group

Jon Speer

Founder and VP of QA/RA, greenlight.guru

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
  • Learn more about Medical Device Single Audit Program (MDSAP) and Other Third Party Programs
  • Explore upcoming changes in global regulation
  • Supply Chain Optimization
  • Criteria for Medical Device commercialization success
  • Panel Discussion
    • Advanced Technology
    • How to choose Vendors/Suppliers

Find out who had attended the Medical Device Summit 2014 and 2015 by completing the short form below.

Format:

The ComplianceOnline Medical Device Summit will include the following:

Keynote Addresses

Leading medical device experts and company executives give their view of the current issues and future challenges in the industry.

Focused Workshops

Expert-led workshops that will help those medical device professionals starting out in their careers and even more senior professionals who need to brush up on new technologies, regulations, processes and more.

Panel Discussions

Panels comprising some of the well-known thinkers and innovators in medical device technology, regulatory compliance and quality will discuss and debate the hottest issues that are affecting the industry. Attendees will be able to interact with panel members during these debates and get unparalleled insight into the state of the industry.

Networking Sessions

Attendees will get to interact with and meet the leading decision makers in the industry in order to exchange ideas, discuss business opportunities and share strategies in focused, small groups.

Multiple Tracks

The Summit will have event tracks dedicated to topics affecting each division/segment of the medical device industry

Exhibitors' Stalls

A unique opportunity for medical device companies both big and small to market their offerings and identify new business opportunities.

Post-Event Community Access

Attendees will get access to an online community that ensures they can continue to build on the networking opportunities and interest that began during the event.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
8:00 - 8:30 am

Registration and Breakfast

8.30 - 8.35 am

Opening Ceremony and Introduction

8:35 - 8:45 am

Welcome Speech with an Introduction of ComplianceOnline & Summit

8:45 - 9:10 am

Medical Devices and the Future of Outcomes Centricity

9:10 - 9:40 am

FDA Enforcement - Outlook & Implications - Panel Discussion

9:40 - 10:20 am

Benefit-Risk: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

10:20 - 10:40 am

UDI Granular Interpretation & Road Ahead

10:40 - 11:10 am

Digital Health and Medical Devices

11:10 - 11:25 am

Networking Coffee/Tea Break

11:25 - 12:05 pm

Medical Device Recall and Complaint Management

12:05 - 12:30 pm

Medical Device Cyber Security (Remote)

12:30 - 1:30 pm

Lunch Break

Track A - Sessions
Track B - Sessions
1:30 - 2:00 pm

Getting Non-dilutive Funding via SBIR Government Grants for Medical Device Development

Interoperable Medical Devices and Connected Medical Networks

2:00 - 2:40 pm

Onward to Approval: Documenting Development for Regulatory Compliance

Clinical Evaluation in the EU for Medical Devices - Changing Expectations

2:40 - 3:00 pm

Networking Coffee/Tea Break

3:00 - 3:30 pm

Wearable Devices (Remote)

3:30 - 4:10 pm

Risk Management for Medical Devices - Workshop

4:10 - 4:30 pm

Closing Remarks - Next Day Plan

8:00 - 8:30 am

Registration and Breakfast

8:30 - 9:00 am

FDA Data Integrity Program

9:00 - 9:30 am

Bringing Compliance to the Boardroom - Panel Discussion

9:30 - 10:00 am

FDA Upcoming Electronic Submission Process

10:00 - 10:30 am

Medical Device Recall and Complaint Management

10:30 - 10:55 am

What Investors are Looking for In Medical Devices

10:55 - 11:10 am

Networking Coffee/Tea Break

11:10 - 11:40 am

How Patent and Regulatory Exclusivity can Protect Your Business

11:40 - 12:15 pm

Compliance as an Element of M&A Strategy - Panel Discussion

12:15 - 12:45 pm

Future Trends in Healthcare and How You Can Profit From Them

12:45 - 1:45 pm

Lunch Break

Track A - Sessions
Track B - Sessions
1:45 - 2:25 pm

FDA Compliance for SaaS/Cloud Environments

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

2:25 - 2:50 pm

The New Off-Label

FDA Quality Metrics Update

2:50 - 3:10 pm

Developing a Global Strategy for Labelling

Early R&D Best Practices from Concept to First in Human Studies

3:10 - 3:25 pm

Networking Coffee/Tea Break

3:25 - 4:00 pm

Vendors/Suppliers - Are You Choosing them Right? - Panel Discussion

4:00 - 4:15 pm

Closing Remarks & Certificates

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

2015 and 2016 SUMMIT SPEAKERS

Speakers from FDA

Ron Brown

Branch Chief for Medical Device Recalls, FDA

Marisa White

Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH

Robin Newman

Director, Office of Compliance, Center for Devices and Radiological Health, FDA

Seth D. Carmody, Ph.D

Cybersecurity Project Manager, CDRH

Bakul Patel

Associate Center Director for Digital Health at FDA

Chrissy Cochran

(Acting Director,
Division of Enforcement and Postmarketing Safety at FDA,)

Bill MacFarland

(Director, Division of Enforcement B,
Office of Compliance, FDA/CDRH)

Erin Keith

(Director, Division of Anesthesiology, General Hospital

Cisco Vicenty

(Acting-Branch Chief, Office of Compliance CDRH/FDA)

Neil Mafnas

(Assistant Regulator CDRH/FDA)

Ann Ferriter

(Director, Division of Analysis and Program Operations CDRH/OC at FDA)

James Saviola

(Deputy Director of Regulatory Affairs (Acting), and Director,

Experts from Industry

Rick Williams

Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics

French Caldwell

Chief Evangelist, MetricStream

Michael Weickert

Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business

Minda Wilson

Founder, Affordable Healthcare Review

Fletcher Wilson

CEO and Founder, InterVene Inc

David Nettleton

Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA, Software Validation, and Computer System Validation

Geetha Rao

CEO, Springborne Lifesciences

Andrew Pfeifer

Account Executive, REED TECH

Angela Bazigos

CEO, Touch Stone Technologies Silicon Valley

Darin Oppenheimer

(Regulatory Affairs Expert, Global Medical Device Regulations & Licensure Authority, Strategic & Engaging Leader, Baxter Healthcare Corporation)

Dr. Ron Weissman

(Chairman, Software SIG, Band of Angels)

Terri Jollymour

(Sr. Director, Operations Readiness & Convergence
Johnson & Johnson Corporate Supply Chain Quality & Compliance)

Haley Lentz

(GUDID Submission Subject Matter Expert, Reed Tech)

Mitch Levinson

(Founder, President & CEO, Cerebrotech Medical Systems)

Mark Mitchell

(SVP Corporate Development at MetricStream &
Business head ComplianceOnline)

Kevin Fleming

(National Healthcare Managing Director at Newport Board Group)

Peter Pitts

Chief Regulatory Officer, Adherent Health, LLC.

Daphne Walmer

Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications

Rohit Bedi

Senior Vice President of Partnerships, MetricStream

Stan Mastrangelo

Professor, Center for Applied Health Sciences, Virginia Tech University

Patrick Rousche

Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc

Brian Shoemaker, Ph.D.

Principal Consultant, ShoeBar Associates

Keith Morel,Ph.D.

VP, Regulatory Compliance, Qserve Group US Inc.

Virginia A. Lang, Ph.D.

President & Chief Scientist, HirLan, Inc.

Eduardo Cervantes

(President & CEO Morf Media Inc)

Tom Loker

(Businessman | Author | Speaker, Startup Consultant and Advisor SYDK.ORG, Contributor to California Political Review)

Scott Phillips

(President Starfish Medicals)

Susan W. Neadle

(Head, Combination Products Center of Excellence Sr. Director,

Gunjan Sinha

(Executive Chairman, MetricStream)

Julia Rasooly

(CEO, Puracath)

Joe Franchetti

(FDA Regulatory Compliance Specialist, JAF Consulting Inc)

Jon Speer

(Founder and VP of QA/RA, greenlight.guru)
Ron Brown Branch Chief for Medical Device Recalls, FDA

Top
Marisa White Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH

Marisa White is the Regulatory Misconduct & Complaints Lead CSO for the Division of Bioresearch Monitoring (DBM) in the Office of Compliance at FDA's Center for Devices and Radiological Health (CDRH). Marisa started at the FDA in the International Operations Branch under the Office of Regulatory Affairs (ORA), where she was involved in the coordination of FDA foreign inspections as the Bioresearch Monitoring (BIMO) Program Team Lead. Prior to FDA, Marisa worked at the New York Blood Center as a Research Assistant before becoming a Clinical Research Program Coordinator at Johns Hopkins University in the Oncology Department, where she managed data and regulatory requirements for various multi-center protocols, with coordinating center responsibilities. Marisa also served as a Sr. Research Program Coordinator for the Leukemia Research Group with responsibilities for training and SOP writing/updates. After Hopkins, she held several roles at a clinical research organization (Covance, Inc.), one of which was a Clinical Research Associate (CRA) involved the set-up and monitoring of clinical trials. Marisa holds a BS in Biotechnology & minor in Biochemistry from Rutgers University and a CCRP certification from SoCRA.

Top
Robin Newman Director, 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).

Top
Seth D. Carmody,Ph.D Cybersecurity Project Manager, CDRH

Dr. Carmody is currently working as the Cybersecurity Project Manager in the Office of the Center Director, Emergency Preparedness/Operations & Medical Countermeasures. Seth also serves as a subject matter and policy expert with CDRH's Cybersecurity Working Group.

Seth joined the FDA's Center for Devices and Radiological Health in 2011 as a medical device reviewer in the Division of Chemistry and Toxicology Devices where his duties focused on premarket approval of diabetes-centric devices and software recalls.

Top
Bakul Patel Associate Director for Digital Health at FDA

BAKUL PATEL is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.

Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairs the International Medical Device Regulators Forum (IMDRF) “software as a medical device” working group, a global harmonization effort.

Before joining FDA, Mr. Patel held key leadership positions working in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations.

Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University

Top
Chrissy Cochran Acting Director, Division of Enforcement and Postmarketing Safety at FDA

Top
Bill MacFarland Director, Division of Enforcement B, Office of Compliance, FDA/CDRH

William MacFarland is the director of the Division of Enforcement B within the Office of Compliance. In this position, he is responsible for overseeing the division’s 33 member review staff who review PMA Manufacturing Sections, Establishment Inspection Reports, recall classifications and compliance cases.Previously, Mr. MacFarland worked in CDRH’s Office of Device Evaluation as both a reviewer and Deputy Division Director in the Division of Cardiovascular Devices. Prior to his current work at FDA he was a consultant with Quintiles Consulting where he was responsible for providing clients with strategic regulatory guidance and managed their 510(k), PMA and IDE projects. Additionally, he developed medical product test strategies, provided review of non-clinical protocols and reports, and provides guidance on compliance with Design Controls throughout medical device development. Mr. MacFarland has also worked for Angiosonics, Inc. of Morrisville, NC as Director of Regulatory Affairs.

Mr. MacFarland received his MBA from University of Maryland in College Park, MD, and his MS in Biomedical Engineering from Case Western Reserve University in Cleveland, OH. He received his BS in Electrical Engineering from Clarkson University in Potsdam, NY. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence and Certified Reliability Engineer.

Top
Erin Keith Director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, CDRH, FDA

Erin Keith is the Director for the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices (DAGRID) in the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health (CDRH). As the DAGRID Director, Ms. Keith provides executive oversight of the division’s premarket programs and review policy for a wide-range of medical device product lines; establishes the division strategic priorities; and supervises a diverse staff of medical, engineering and scientific staff. In her management role in DAGRID, she oversees DAGRID’s implementation of a unique risk-management pilot program, the Safety Assurance Case for Infusion Pumps. She also continues to teach on risk management topics, and represents CDRH in international standards development and harmonization activities.

Prior to her current position with DAGRID, Ms. Keith was the Deputy Director for Science and Policy for the Division of Orthopedic Devices (DOD) in ODE from May 2011 to November 2013. In DOD she provided oversight of the division implementation of review policy and scientific review issues. Additionally, Ms. Keith was the Assistant Country Director for Medical Devices at the US FDA New Delhi Office from February 2009 until May 2011. As an Assistant Country Director, Ms. Keith was responsible for analyzing the Indian medical device industry’s capabilities for meeting US regulatory requirements and developing a program to increase the Indian industry’s knowledge of US medical device regulatory requirements.

Top
Cisco Vicenty Acting-Branch Chief, Office of Compliance CDRH/FDA

Top
Neil Mafnas, LCDR, USPHS, M.S. ASSISTANT REGULATOR CDRH/FDA

Lieutenant Commander Neil A. Mafnas is a Regulatory Officer in the United States Public Health Service Commissioned Corps. He is currently assigned to the Medical Device Single Audit Program (MDSAP) Team in FDA’s Center for Devices and Radiological Health, Division of International Compliance Operations. As a member of the MDSAP Team, LCDR Mafnas’ duties include the creation/development of policy, procedures, training and conducting outreach. Additionally, Neil serves as a Subject Matter Expert and Project Manager for the development/implementation of MDSAP’s IT Portal. Neil began his career with the FDA in 2010 as a Consumer Safety Officer (CSO) in the Office of Compliance at the Center for Devices and Radiological Health. As a CSO in the General Hospital Devices Branch, he worked on medical device inspection classifications, recall classifications, medical device complaints and Consent Decrees for Permanent Injunction. Neil also works closely with the Association for the Advancement of Medical Instrumentation as one of the Agency’s Quality System Regulation instructors. LCDR Mafnas has been in the Public Health Service since November 2011. Prior to coming to the FDA, he worked as the Safety Manager for a logistics firm. Neil also served in the United States Air Force as an active duty Space and Missile Maintenance Officer from 2001 – 2007. LCDR Mafnas holds a Bachelor’s Degree in Biology from the University of Texas at Arlington, and a Master’s of Science in Health Sciences from the University of Central Florida.

Top
Ann Ferriter Director, Division of Analysis and Program Operations CDRH/OC at FDA

Top
James Saviola Deputy Director of Regulatory Affairs (Acting), and Director, Division of Biomedical Research, Office of Compliance, CDRH

Dr. James Saviola joined the Center for Devices and Radiological Health (CDRH) in 1986. He is a Captain in the U.S. Public Health Service and holds consulting staff credentials with the Optometry department at the Walter Reed National Military Medical Center, Bethesda, MD. Jim was a branch chief in the Office of Device Evaluation involved with ophthalmic devices from 1991 until January 2008. He then served three years in the Center Director’s Office where he was responsible for helping to promote information exchange within CDRH to better identify and analyze medical device risks and develop public health responses. Jim has been with the Division of Bioresearch Monitoring in the Office of Compliance since January 2011. He’s been serving as the BIMO Director since the fall of 2011. Under his direction the division has focusing on developing expertise in various program areas and expanding support of Class II medical device clinical study activities.

Top
Rick Williams Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board Member of Amorphex Therapeutics

As Chairman of the Board for an international medical device company,led successful strategic repositioning work in response to the evolving technology, market and financial environment. The repositioning involved a product transition from hardware to disposables.Lead funding initiatives with private and VC investors. Founded and led an award winning real estate development company. As Board Chair, led the transformation of a quasi-public state agency into a one stop center for small firms lacking access to conventional financing. Led large projects for public and private clients on the impact of regulation on major US industries. He as helped numerous companies and investors evaluate new business opportunities.

Board member of VC backed med tech company bringing slow release long term drug delivery product to market.

Top
French Caldwell Chief Evangelist, MetricStream

One of the foremost thought leaders in IT, French Caldwell has been decisively shaping the GRC market for the last 12 years.

French is a former Fellow and Vice President at Gartner where he led their GRC research, including the influential Gartner Magic Quadrant on GRC, as well as research into disruptive technology. He also worked with the White House and U.S. Naval War College in 2002 to develop the Digital Pearl Harbor war game, the first ever strategic assessment of cyber war strategies. In 2012, the game took on a very real form with the strategic attacks on oil and gas infrastructure in Saudi Arabia and Qatar. French is also a retired naval officer and a nuclear submariner. Post-retirement, French served as a diplomatic liaison to NATO for the post-Cold War Congressional Commission on Roles and Missions of the Armed Forces.

As an academic, French served as a Federal Executive Fellow at the Brookings Institution, an Adjunct Fellow at the Center for Strategic and International Studies, and an Adjunct Professor and Graduate Research Advisor at the George Washington University School of Engineering Management. He has written a book on international law, and has over 400 published research papers.

French has a PhD in Law and Policy, an MA in International Economics, Strategy and Diplomacy, and a BS in Oceanography.

Top
Michael Weickert Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business

Top
Minda Wilson Founder, Affordable Healthcare Review

Minda Wilson, J.D., is an author, entrepreneur, and a corporate attorney, specializing in healthcare. A recognized expert on the Patient Protection and Affordable Care Act, she consults with clients regarding its proper implementation. She is founder of Affordable Healthcare Review, an educational organization providing information about healthcare legislation, its application, and impact. For more than 20 years, Wilson has worked with companies in the areas of productivity improvement, crisis management, corporate organization, business and financial planning, and fraud detection.

Top
Fletcher Wilson CEO and Founder, InterVene Inc

Fletcher Wilson is the Founder and CEO of InterVene, Inc., a start-up medical device company working in the peripheral venous space. Fletcher raised a Series A with subsequent closings from an investor base of over 60, including a corporate strategic, two venture capital firms, three angel groups, and various individuals. He is the first named inventor on two issued patents, and numerous active applications in the interventional venous space. Prior to InterVene, Fletcher was a Stanford Biodesign Fellow, where he and his teammates identified the clinical need and initial solution that would become InterVene. Prior to Biodesign, Fletcher was an R&D engineer at a two person device start up, InSite Medical, and an R&D intern at Boston Scientific. Fletcher received his Master's degree in Mechanical Engineering from Stanford University and his Bachelor's Degree in Mechanical Engineering from the University of Pennsylvania.

Top
David Nettelton Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA, Software Validation, and Computer System Validation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Top
Geetha Rao CEO, Springborne Lifesciences

Top
Andrew Pfeifer Account Executive, REED TECH

Andrew works closely with a team of Subject Matter Experts at Reed Tech to provide submission solutions based on industry needs. Areas of expertise include coordinating with leaders spanning multiple business units in managing complex data submissions to the FDA as well as advising on best practices regarding recent UDI mandates. Additionally, he maintains high levels of Structured Product Labeling and XML conversion practices as well as downstream application and concerns of XML-driven data.

Top
Angela Bazigos CEO, Touch Stone Technologies Silicon Valley

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.

Top
Darin Oppenheimer Regulatory Affairs Expert, Global Medical Device Regulations & Licensure Authority, Strategic & Engaging Leader, Baxter Healthcare Corporation

MS is a Regulatory Affairs Director at Baxter Healthcare. Based in the Chicago Area, Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Darin leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise.

Top
Dr. Ron Weissman Chairman, Software SIG, Band of Angels

Dr. Ron Weissman was vice president of strategy and corporate marketing for Verity, a global leader in corporate information retrieval and knowledge management. During his tenure at Verity, the executive team earned the large company "turnaround of the year" award (1999) from the Turnaround Management Association; Verity gained dominant market share and saw its market capitalization grow from $50 million to more than $1.5 billion. Prior to Verity, Ron spent more than five years at NeXT Computer, where he managed European and corporate marketing. In addition to his work in Silicon Valley, he ran academic computing at Brown University and at the University of Maryland, where he was Associate Professor of History. He is the author of two books on the history of Florence during the Renaissance.

Top
Terri Jollymour Sr. Director, Operations Readiness & Convergence Johnson & Johnson

Terri Jollymour is a member of the Operations Readiness & Convergence (ORC) enterprise group, leading strategic efforts in the convergent space for Johnson & Johnson (J&J). Terri works across the three main business sectors: Consumer/McNeil, Janssen Pharmaceuticals, and Medical Device & Diagnostics to ensure safety, quality and sustainability for the convergent space.

Within J&J’s Convergent Space, Terri is responsible for comprehensive engagement with project teams to assess and mitigate new product development for product, process and program risks. This spans across early to late development and pre-launch readiness. Terri is also accountable for strategic leadership initiatives in the Supply Chain organization, such as leading the implementation of the Combination Product CGMPs. Terri’s group is responsible for ad hoc support for convergent programs, to address specific issues or fill in specific roles on teams. Her group is also responsible for rapid tactical reponse for supply chain and/or quality and compliance mitigation issues across the enterprise. Terri leads the Convergent Network at J&J, which brings all three business sectors together for learning, sharing/leveraging and networking within this innovative space.

For over a decade, Terri has held top leadership roles in the convergent space within J&J. She has been responsible for leading large, complex, convergent product development program teams within J&J’s pharmaceutical and medical device & diagnostic sectors. She has been recognized for her outstanding leadership with numerous company recognition awards and executive programs.

Terri earned her degree in Pharmacology at the University of California, Santa Barbara. Prior to J&J, she worked in the diagnostic space at Syva and led controlled release drug-delivery programs (combination products) at ALZA Corporation. She held positions of increasing responsiblities within program management, R&D, analytical sciences and quality assurance over her many years in the health care industry. She is a member of the Healthcare Businesswomen’s Association and is a certified Project Management Professional. Terri is married and has three children and three dogs! She enjoys swimming with her masters team, cycling, hiking and skiing. She resides in Northern California.

Top
Haley Lentz (GUDID Submission Subject Matter Expert, Reed Tech)

Haley Lentz is the Account Executive for the Life Sciences Division at Reed Tech. She is responsible for providing a GUDID submission strategy for medical device manufacturers based on a consultative, needs-based assessment.

Haley works closely with a team of Subject Matter Experts at Reed Tech to provide submission solutions based on industry needs. Areas of expertise include coordinating with regulatory affairs leaders in managing complex data submissions to FDA as well as advising on best practices regarding recent UDI mandates. Additionally, she maintains high levels of Structured Product Labeling and XML conversion practices as well as downstream application and concerns of XML-driven data.

During her time at Reed Tech, Haley has collaborated to publish two articles on UDI implementation, “US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know” and “Six Recommendations Regarding Upcoming UDI Compliance Dates”.

Top
Mitch Levinson Founder, President & CEO, Cerebrotech Medical Systems

Mr. Levinson is a start-up medical device executive with over 30 years of experience developing and bringing revolutionary new products to market. Mr. Levinson started Cerebrotech Medical Systems in 2011 based on a technology developed at UC Berkeley with the goal of improving care for brain injury patients with a noninvasive monitor to detect early stages of cerebral edema and bleeding. Mr. Levinson was the start-up President and CEO for Zeltiq Aesthetics, brought in by the investors, Frazier Healthcare Ventures and Advanced Technology Ventures, as the company's first employee. Zeltiq's groundbreaking cooling technology was licensed from Massachusetts General Hospital for non-invasive fat layer reduction. Mr. Levinson built the company from the ground up and launched the product 3 years later, in what has become widely regarded as one of the most successful medical device launches in the aesthetic space. Zeltiq has quickly become the world's premier fat layer reduction technology and is found in thousands of physician offices in the US and around the world. Zeltiq held its IPO in October of 2011 and by 2014 exceeded a market cap of $1 billion. Prior to Zeltiq, Mr. Levinson was the first technical employee at Thermage, where he led the product development as its founding Vice President of Research and Development. Thermage utilizes a radiofrequency-based technology and was the first device to provide non-invasive skin tightening. That company held its IPO in 2006, and has become a mainstay in aesthetic dermatology and cosmetic surgery physician practices. It is now part of Valeant Pharmaceuticals. Mr. Levinson was also the founding Vice President of R&D at BioSurgical Corporation, developer of a novel applicator for fibrin sealant, acquired in 2000 by Baxter International. Mr. Levinson has served as a product development executive at Nellcor (patient monitoring), Baxter (in vitro diagnostics), and as an engineer at ALCOA Intercon-X, and Hewlett Packard. Many of Mr. Levinson's innovations are represented in his 37 issued U.S. patents with more pending. He earned his B.S. in Engineering Sciences from University of California at San Diego and also holds a MS in Computer Systems from University of Phoenix.

Top
Mark Mitchell SVP Corporate Development at MetricStream & Business head ComplianceOnline

Mark has over 25 years of experience in enterprise software, corporate and business development, and mergers and acquisitions in various Silicon Valley technology companies. He played a key role in building valuable technology businesses in the US and globally, in several C-level roles. He was a co-founder at eMeter, a leading smart-grid company acquired by Siemens AG. He also held key operating executive and corporate and business development leadership roles at Serious Energy, Intematix, Scayl, and Law.com.

Most recently, Mark was SVP Business Development at RiverMeadow, a leading provider of SaaS solutions for migration of servers into the Cloud. Mark’s experience spans a range of businesses, including Fortune 500 and Global 1000 customers in the Americas, EMEA, and APAC. He is also a named inventor on three patents.

Mark holds a Master’s degree in Business from Stanford University’s Graduate School of Business, a Juris Doctorate from the University of California, Hastings College of the Law, and a Bachelor’s degree in Computer Science from University of the Pacific.

Top
Kevin Fleming National Healthcare Managing Director at Newport Board Group

Kevin has over 30 years of senior executive experience in the Health Care, Financial Services, Technology and Professional Services Industries in roles including CEO, President, COO, Managing Director and Senior Partner.

  • Newport Board Group - Partner 2013 - Current
    • Managing Director of Nationwide Healthcare & Life Sciences Consulting Practice with 29 professionals, most former CEO's. Overall firm has nearly 100 partners nationwide.
    • ePAY Healthcare - Acting CEO and Board Member (2013 - Current)
      • Nationwide Healthcare IT SAAS Company with operations in 42 states serving over 650 Hospitals, Ambulatory Surgical Centers and other providers.
      • Comprehensive Patient Responsibility Financial Management Platform to maximize patient revenue collections and introduce innovative lending and other financing options.
      • Responsible for all primary aspects of the company.
    • Leads/Directs M&A Buy and Sell, IPO, Capital Raising and other events.
    • Serves as a Board member for US Community Behavioral Health, a nationwide provider in Behavioral Health and Traumatic Brain Injury Post-Acute Care Rehabilitation.
    • Performs strategic Board and CEO level consulting and advisory projects for clients.
  • Paradigm Outcomes - CEO 2006 - 2012
    • Nationwide Catastrophic Injury and Chronic Pain management full service and risk taking Healthcare Accountable Care Organization (ACO)
    • Served also in progressive capacities as Board Director, President, CFO & COO
    • Orchestrated a highly successful turn around and monetization of the company.
  • Electronic Data Systems - Managing Director 2003-2006
    • Executive Leader for a very large strategic business unit serving the healthcare and financial services industries. Clients included Blue Shield, McKesson, UCSF Medical, HSBC, Visa and Citigroup.
    • Achieved significant top line and bottom line growth while securing key new logo revenue clients.
  • Ernst & Young - Senior Partner 1980 - 2000
    • Coordinating Partner for major accounts including Healthnet, Foundation Health, Bank of America, Wells Fargo and others. One of the youngest partners in the firms history.
    • Chairman and executive leader of a very successful nationwide M&A and post merger integration practice
  • Professional Groups - Bay Area Alliance of CEO's, Financial Executives Institute (FEI), AICPA & California CPA Societies.
Top
Peter Pitts Chief Regulatory Officer, Adherent Health, LLC.

Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee.

Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, DTC/ItP, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling.

In 2010, he was named by Modern Healthcare magazine as one of the 300 “most powerful people in American healthcare.”

His comments and commentaries on health care policy issues regularly appear in The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, The Boston Globe, The Washington Times, The Chicago Tribune, The Chicago Sun Times, The San Francisco Examiner, Investor’s Business Daily, The Baltimore Sun, The Economist, Nature Biotechnology, The Journal of Life Sciences the BBC World Service, Fox News, and The NewsHour with Jim Lehrer, among others.

Top
Daphne Walmer Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications

Daphne Walmer is a former Director of Technical Communications at Medtronic who pioneered the use of electronic manuals in the medical device industry. Her group obtained approval to test eIFUs in the European Union for 10 years before their approval in 2013. She helped review the EU regulation for the industry, and led the effort for Medtronic to comply with its requirements. She currently consults in the areas of management of user documentation, translation and localization, and component content management systems.

Top
Rohit Bedi Senior Vice President of Partnerships, MetricStream

As the SVP of Partnerships, Rohit is responsible for leading global partnerships by enabling the influence, distribution and delivery capabilities of our partners.
In a career that spans the full lifecycle of enterprise software, Rohit has been involved with building dominant software brands and successful companies in leadership roles. Most recently, Rohit led large company partnerships and strategic business in enterprise software at Cognizant. Prior to that, he was part of the executive team at Cymbal where he managed worldwide sales, marketing and partnerships leading to a successful acquisition. In the growing days of Seibel, he was responsible for an entire product line at Siebel Systems including expanding the partner network which played a big role in Siebel’s distribution and delivery channel expansion. He was also in Product marketing roles at PeopleSoft.

Rohit is very passionate about coaching young juniors and has advised growing entrepreneurial firms in software and services. He has also helped institutions that support talented underprivileged children in golf. Rohit received his MBA from Harvard University, M.S. from the University of Alabama, and B.E. from Delhi College of Engineering, all with honors.

Top
Stan Mastrangelo Professor, Center for Applied Health Sciences, Virginia Tech University

Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.

Top
Patrick Rousche Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc

Top
Brian Shoemaker Ph.D., Principal Consultant, ShoeBar Associates

Brian Shoemaker provides consulting services and training in computer system validation, software quality assurance methodology, and electronic records and signatures. His projects have included validating process-equipment software, validating embedded medical-device software, developing software quality systems, assisting companies through regulatory-compliance projects, and evaluating systems for 21 CFR Part 11 compliance. His clients have included firms in the medical-device fabrics manufacturing, plastics molding, contract lyophilization, outsourced medical device engineering, clinical trial software development, dental prosthetics, and bone-repair implant fields. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian served as Quality Assurance Manager at PPD Informatics (now CSS Informatics), QA/Validation for Doxis, Inc., and Systems Engineering Manager at Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Top
Keith Morel, Ph. D VP, Regulatory Compliance, Qserve Group US Inc

Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations.

He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer) where he was responsible for Internal and External audit processes & execution, Management Review, QMS design & governance and the internal Training process. He was also a Senior Project Manager for DEKRA Certification Inc. for 9 years. During his time at DEKRA he was lead auditor for CE (MDD) & ISO 13485:2003 and performed more than 100 audits & more than 200 Design Dossier/Technical File reviews. He was also DEKRA’s senior cardiovascular product expert, as well as a drug-device combination product expert and he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification.

Dr. Morel has also worked in R&D in the Medical Device industry in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products. He has both a Ph. D. in Plasma Physics (Nuclear Fusion) and a First Class Honours degree in Physics from Imperial College of Science, Technology and Medicine, in the UK

Top
Virginia A. Lang, PhD President & Chief Scientist, HirLan, Inc.

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients’ FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.

Top
Eduardo Cervantes President & CEO Morf Media Inc

Eduardo Cervantes is President and CEO of Morf Media, a leading compliance training system vendor which is enabling the Millennial, and subsequent generations to effectively train on compliance. Previously, Eduardo led several successful exits through M&A in the technology industry domestically and in Europe. He started his career in M&A with Goldman Sachs where he worked major consumer and pharma transactions. Eduardo holds an MBA and an MS from the University of Texas at Austin.

Top
Tom Loker Businessman | Author | Speaker, Startup Consultant and Advisor SYDK.ORG, Contributor to California Political Review

Tom has had an extensive history in healthcare. As an Angel Investor, Mentor and Advisor at Keiretsu Forum & Venture-Med and an established operations guy with serial successes with startups, transitional companies and turnaround situations, Tom has had a long career serving in the fields of science, technology and healthcare related industries. He is an active board member in both for-profit and not-for-profit companies. Tom has written numerous articles in the areas of healthcare, health tech, health policy, politics and the economy of healthcare. He is currently the principal author, along with a number of other contributors, of Health Reform 2.0: Beyond partisan divide lies pragmatic solutions – a working whitepaper focused on moving beyond the partisan rhetoric of the ACA (Obamacare) to a simple, efficient, effective, accessible and affordable healthcare system.

Tom has been involved with healthcare reform for many years, going back prior to President Obama’s election. He was active during the debate, advising on how to effectively get services to the underserved. He was a strong advocate for using true patient centered systems to improve the quality of care and patient outcome and was pivotal in the insertion of the concept of coordination of care and benefits as a repeated tenant of the Affordable Care Act. Tom is one of the few people that has read almost every word of every piece of legislation that came out of the various committees, as well as the various versions of the final legislation.

Tom’s understanding of the history of care in America helpes him get others to understand how we got to the non-system we have today, as well as how this system needs to fundamentally change in order to develop into the system we need for tomorrow. Tom's work on this whitepaper, mentioned above has been heralded as a fresh and valid approach to move beyond the ACA, or Obamacare, and get to a truly workable solution.

In the healthcare space, Tom has long maintained a passion for serving the underserved and has founded, supported and worked in various companies to serve the most fragile among us. He has developed a number of detailed approaches to solving the issues in the current, and evolving healthcare system. Because of his understanding and expertise in the business of healthcare, he has been invited to conduct multiple congressional briefings on healthcare reform in Congress, meeting with more than 100 congressional representatives.

Top
Scott Phillips President, Starfish Medicals

Scott holds a degree in Engineering Physics from the University of British Columbia. Prior to starting StarFish, he worked in diverse areas such as lithium battery development and manufacturing, UV spectroscopy instrumentation and hi-fi audio speakers. Under his leadership StarFish has grown from being a highly motivated team working on one project at a time to a diverse professional organization with clients around the world and 100% focus on medical devices.

Top
Susan W. Neadle Sr. Director Janssen Pharmaceuticals

Susan W. Neadle is a member of Janssen’s Global Product Quality Leadership and is a Design Excellence Black Belt. Her accountabilities span from leading Janssen’s Combination Product Center of Excellence to creating new quality frameworks for emerging platforms and technologies, Design-to-Value, criticality analysis and risk management, and Quality Engineering for Janssen’s portfolio of products.

Over her extensive career, Susan has played integral leadership roles in the product and process development of over a dozen new products. She was awarded the Johnson Medal, Johnson & Johnson’s highest honor for innovation excellence, for invention and development of a product platform central to J&J Vision Care’s portfolio. This technology was also awarded the “SILMO Award” for Innovation, Technology & Creativity in Europe, and the “Good Design Award” in Asia.

Susan’s experience includes enabling and applying advanced product and process analytics to drive proactive process capability and product quality. She is a core-team member of the J&J Convergent Technologies Network. She has been recognized for her contributions in CTQ Flow-Down, DTV and PLM Initiatives, to drive improved robustness in product quality through the end-to-end lifecycle management.

Susan earned an M.S. in Polymer Science & Engineering, and a B.S. in Biology/Chemistry, and Fellowships in the American Academy of Optometry and the British Contact Lens Association. Prior to joining J&J, she held R&D, quality, and commercialization positions at Unilever, Organon Teknika, and IBM. In these positions she worked in controlled release technology, biomedical diagnostics, and materials analysis.

In addition to Susan’s professional experience, she holds numerous patents, has written a variety of papers, and has frequently presented on topics related to her contributions to, and areas of subject matter expertise in, the medical device and pharmaceutical industries.

Top
Gunjan Sinha Executive Chairman, MetricStream

Gunjan Sinha is responsible for leading MetricStream’s overall strategy and execution. Gunjan currently serves on the Board of Directors of several Silicon Valley companies, and was appointed in 2010 to the Board of the US-India Science and Technology Research Endowment Fund by the US State Department to promote entrepreneurship and innovation. Additionally, he is the Chairman of CFHI.org which brings transformative healthcare education to under-served communities.

Over the course of his career, Gunjan has spent over 20 years in various entrepreneurial, board, and executive positions building innovative businesses. He was the Co-Founder and President of WhoWhere? Inc., a leading Internet directory services company that was acquired by Lycos in 1998, as well as eGain, an online customer service company which he built from inception to post NASDAQ IPO.

Gunjan obtained his BS and MS degrees in Computer Science from the Indian Institute of Technology, New Delhi, and UC Santa Cruz, respectively. He also holds an MS in Industrial Engineering and Engineering Management from Stanford University. Gunjan has been featured as one of the 50 most successful immigrant entrepreneurs in the US by Silicon India.

Top
Julia Rasooly Founder and CEO, PuraCath Medical Inc

Ms. Rasooly is the Founder and CEO/ President of PuraCath Medical -- a medical device startup in home dialysis and was spun out of Stanford University during her graduate school education in 2012. Ms. Rasooly has over twelve years of experience in R&D in medical device and biotech industries. She is focused on revolutionizing the dialysis industry and bringing her novel home dialysis technology to make dialysis at home safer and more affordable. Prior to being the Founder and CEO of PuraCath Medical, she was a researcher at the renowned Molecular Imaging Laboratory at Stanford University School of Medicine, where she worked on stem cell therapy and imaging projects. Julia has obtained a B.Sc. in Bioengineering from the University of California Berkeley, an M.S. in Bioengineering from Stanford University, an M.S. in Medicine from Stanford University, and a Certificate from the Summer Institute for Entrepreneurship from the Stanford Graduate School of Business (GSB). She took a “leave-of-absence” from her PhD program in Bioengineering from Stanford University to grow PuraCath on a full-time basis. She has won multiple honors and awards, including the Howard Hughes Medical Institute Medical Scholar, the National Ford Foundation Pre-Doctoral Fellowship, the National Coca-Cola Scholarship, and multiple other governmental grants and awards for start-up ventures. She also is the co-founder and President of two non-profits focused on tech entrepreneurship as well as women entrepreneurs in healthcare.

Top
Joe Franchetti FDA Regulatory Compliance Specialist, JAF Consulting Inc

As JAF Consulting, Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation in regulated environments. For over 20 years, Joe has been involved with the development, purchase, installation, operation and maintenance of computerized systems used in all phases of drug development. In addition, Mr. Franchetti has over twenty five years of progressive experience in information technology and data management in the pharmaceutical and lie science industry.

He has extensive experience with all aspects of computer systems validation and compliance and is involved with the ACDM Clinical Research-CSV Working Party working on a chapter on GAP analysis, and has recently been involved with a chapter on Risk Assessment for the recently released DIA PEACH publication on Computerized Systems used in Clinical Trials and has also been involved with the GAMP Special interest Group on Laboratory Systems publication. Joe is currently the Training Chairperson for the Society of Quality Assurance’s Computer Validation Initiative Committee.

Top
Jon Speer Founder and VP of QA/RA, greenlight.guru

Jon is the Co-founder & VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality management software exclusively for medical device companies. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance & project management. Jon started his career in the medical device industry over 16 years ago as a product development engineer after receiving his BS in chemical engineering from Rose-Hulman Institute of Technology.

Top
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$999.00

Seminar One Registration

June 8-9, 2017, Boston, MA
(Registrations till February 25, 2017 - $999)
(Registrations till March 20, 2017 - $1299)
(Registrations till April 25, 2017 - $1399)
(Registrations till May 20, 2017 - $1499)
(Registrations after May 20, 2017 - $1699)

$1,699.00

Seminar One Registration (With 2 Nights Stay)

June 8-9, 2017, Boston, MA

$4,599.00
$5,994.00 (23%)*

Save $1,395.00

Special Group Discount Register for Six attendees

June 8-9, 2017, Boston, MA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left



Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location :

Boston, MA
(Venue to be announced shortly)

June 8-9, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

As a sponsor and exhibitor, you will share your expertise, showcase your technologies, products, and services, and network with decision-makers from the Medical devices and the renowned R & D experts technology innovators manufactures etc. We are pleased to offer several exhibitor and sponsorship options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Table-Top Exhibitor Package

Table-Top – Your table-top will be positioned in the exhibit hall. The exhibit hall will be open on both the days for the event and during all breaks. Lunch will also be served inside the exhibit hall. Your package includes:

  • Logos on website, marketing email, branding materials & the registration booth
  • One (2’ x 6’) draped table and one chair
  • Exhibitor can bring banner stands or a pop-up booth not to exceed 8’ x 8’
  • Two conference passes

* A confirmation package will be emailed to you with all the conference details, including table-top number.

For more details and other sponsorship options at this Summit, please contact Summit Manager: summit@complianceonline.com or call: +1-650-238-9656

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Testimonials

See What People Say About Us

This event was very focused on FDA regulatory training, standards and guidance. This was the main reason that I attended in this event and the event delivered all with high quality.

Research and Development Program Manager IV,

Abbott

The FDA speakers really added a lot of value. There were many experienced industry speakers & I learned a lot from them.

CEO,

Springborne Life Sciences

The summit was great success on my opinion, very knowledgeable speakers and interesting topics. I extended my network of contacts that beneficiary for our company. Thank you for giving this great opportunity and hoping to attend another one next year.

Quality Assurance Manager,

BCSI SAFE Sens

With notable speaker, a broad range of topics and great networking potential, this conference was an amazingly good investment of time.

Principal Consultant,

Shoebar Associates

There was a very good presence of the FDA, who provided brief regulatory insights.

President and Chief Scientist,

HirLan, Inc.

Excellent mix of topics with great presentations, worth every penny and time we spent there.

CEO,

SEAS, Inc

Excellent speakers, diverse experience and background.

Senior Manager,

Global Security Risk Management, Edwards Lifesciences

Very interesting & informative sessions.

Director,

Device Manufacturing, Vital Therapies

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Frequently Asked Questions:

I have two discounts I would like to use for my summit registration; can I use both of them?
No, we do not combine discounts but we will honor the discount that is better for you.

Are the meals included?
Yes, all refreshments and summit lunches have been carefully selected to offer you the best in banqueting. Please check the agenda for timings.

How many attendees will be at my summit?
This varies for each summit. Please do ask at our registration desk if you would like us to assist in facilitating meetings with anyone present to ensure you receive maximum benefit from the day.

How can I get to the venue?
For information on the venue or travelling details to the summit check the “venue” section on the website or contact us if you require further information.

What about accommodation?
The cost of the hotel accommodation and travel is not included in the registration fee. To take advantage of our corporate accommodation rate, after completing the registration, please state you are attending ComplianceOnline Medical Device Summit when making your hotel room reservation. Please note that special discounted hotel rooms are limited and available on a first-come, first-serve basis.

What should I wear?
Speakers and delegates normally wear formal business attire whilst attending the summit.

In case of special needs?
If you have any special needs, disabilities, and/or dietary requirements please do let us know when you register for the event.

Do I have to pre-select the streams that I want to attend in a multiple stream summit?
Yes, for planning reasons we will need to know who is attending which stream.

When should I pay for the summit?
Payment must be received prior to the summit. To get the early bird price offer, please visit the “Price/Register” section of website.

How should I pay for the summit?
The simplest method of payment is via credit card using our secure online bookings. If you wish to book offline, we require written authorization along with credit card details by e-mail to summit@complianceonline.com. You can also send your PO with summit name and location by fax to +1-650-963-2556. We accept Visa, MasterCard, Maestro and American Express. Pay your check to (payee name) "MetricStream Inc" our parent company and mail the check to: ComplianceOnline (MetricStream, Inc), 2479 East Bayshore Road, Suite 200, Palo Alto, CA 94303.
If you have any questions concerning payment please feel free to contact our customer service team on +1-888-717-2436.

How can I get a receipt for my credit card payment?
There are two ways you can receive a receipt for your credit card payment:
  1. Unless otherwise requested, or if payment is made close to the event date, we will e-mail you your receipt.
  2. We are happy to fax a copy of the receipt for your records until you receive the original. You will need to advise our customer service team which option is preferable.
I am already busy at the time of the summit; can I still get the materials used?
Yes, if you know before booking that you cannot attend the summit, you can purchase materials used at the summit.

When will I receive my summit material?
Depending on whether you are a delegate or a document purchaser, you will receive your summit material at different times:
Delegates: Your badge and delegate pack will be available for collection at registration on the first morning of the summit.
Document Purchaser: Providing that payment has been received documents will be sent out two weeks after the event date.
Online Document Purchasers: Soft copy will be sent out to you via email two weeks after the event.

Can I receive a copy of the presentations?
Yes. All attendees will get a copy of the presentations after the summit. The distribution of presentation materials is subject to the speakers’ permission. If you are unable to attend the event, it is also possible to purchase a CD-ROM that contains presentations from the summit. For more details email us at summit@complianceonline.com.

What happens if I have to cancel?
  1. Cancellations may be made by phone but must be confirmed in writing within a month of the event, please see the event brochure for individual cut off dates.
  2. Please quote the order number and delegate name when cancelling.
  3. Cancellations must be received in writing. Cancellations received more than one month prior to the summit are subject to a $300 administration charge.
  4. Cancellations within 30 days of event date: In the event of cancellation 100% of the event fee is payable and non-refundable. All cancellation requests must be submitted to us in writing. If we agree to your cancellation then all cancellation fees are payable immediately after the acceptance of your cancellation in writing by us.
If you cancel a complimentary delegate place or fail to attend you will be liable to pay a cancellation fee of $200 for the event.

What happens if the event is postponed or cancelled?
In the event that ComplianceOnline postpones or cancels an event, delegate payments at the date of cancellation/ postponement can either be credited to a future ComplianceOnline event or refunded. This credit will be available for up to one year from the date of issuance. If the delegate is unable to attend the rescheduled event, the delegate is welcome to send a substitute delegate, free of charge, or will receive a credit representing payments made towards a future ComplianceOnline event.

Can I substitute a delegate?
Yes, substitution of a delegate is free of charge - we need full registration details before the summit in order to substitute a delegate. For more information on the details feel free to contact our customer service team on +1-888-717-2436.

Can I register at the summit venue?
Yes, you may register for summit on site and our registration personnel will be happy to help you. But we would suggest that you register as soon as possible as seats are limited.

Indemnity
ComplianceOnline is not responsible for any loss or damage as a result of a substitution, alteration, cancellation, or postponement of an event. ComplianceOnline shall assume no liability whatsoever if this event is altered, rescheduled, postponed or cancelled due to a fortuitous event, unforeseen occurrence or any other event that renders performance of this summit inadvisable, illegal, impracticable or impossible. For purposes of this clause, a fortuitous event shall include, but shall not be limited to: an act of God; governmental restrictions and/or regulations; war or apparent act of war; terrorism or apparent act of terrorism; disaster; civil disorder, disturbance, and/or riots; curtailment, suspension, and/or restriction on transportation facilities/means of transportation; or any other emergency.
Please note that speakers and topics were confirmed at the time of publishing, however, circumstances beyond the control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, ComplianceOnline reserves the right to alter or modify the advertised speakers and/or topics if necessary. Any speaker or schedule substitutions or alterations will be updated on our webpage as soon as possible.

Will I receive any information from you via mail?
After the summit, from time to time, you may receive updates on related upcoming seminars, webinars and summits.

Will I receive any e-mails from you?
If you have opted-in to e-mail communication with ComplianceOnline you will receive related market information and advanced notification of related events.

Will my contact details be shared with third parties?
No, ComplianceOnline does not give out your contact details to third parties. From time to time, you may receive information on relevant or related areas from one of our divisions.

How do I prevent SPAM filters from blocking my alerts?
Internet Service Providers (ISPs) utilize various methods to prevent unsolicited commercial e-mail (junk mail or spam) from being delivered to users' mailboxes. Some of these methods may mistakenly classify ComplianceOnline Medical Device Summit emails as such and not deliver the alert to the recipient. Each ISP has different set of steps to follow to assure these alerts get delivered directly to the users' mailboxes. Typically the sender's domain name must be added to an address book or 'safe list'. To assure you receive ComplianceOnline Medical Device Summit alerts via e-mail, please add www.complianceonline.com to your address book or safe list. If you still have trouble, please contact the helpdesk via e-mail at summit@complianceonline.com.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading