Eighth Annual Medical Device Quality Congress

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1 - 9999
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10 CDRH Officials and 5 Former FDAers Scheduled to Speak

If you can only attend one event this year, the 8th annual edition of this conference should be the one. Past attendees have called it a “must-attend” and said “You cannot afford NOT to go to this event.”

This year, our speakers include 10 CDRH and 5 former FDA officials, plus leading experts from the industry. Hear them when you register for the Eighth Annual Medical Device Quality Congress on June 7-9 in Bethesda, MD.

We’ve prepared this program with you in mind. Our exclusive FDAnews survey of device-makers pinpointed your “Top 5” most important quality issues — risk management, design control, supplier quality, QSR compliance and postmarket surveillance — and this year’s program is built around them.

Attend and you’ll get answers to your toughest questions, including:

  • What can you do to improve your QA and engineering processes and better serve patients?
  • What about “sister suppliers” and regulations surrounding supplier management?
  • What are CDRH’s expectations for postmarket surveillance and signal detection?
  • What new problems are field investigators uncovering?
  • What are CDRH’s goals and areas of interest for 2011 — and beyond?
  • And more

And that's just the beginning. During 2 1/2 days of laser-focused sessions and interactive panels, you'll hear from the following CDRH officials and top quality experts:

CDRH Speakers

Steven Silverman, Director, Office of Compliance, CDRH, FDA
Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA (invited)
Marjorie Shulman, Acting Director, Premarket Notification (510(k), Office of Device Evaluation, CDRH, FDA
Larry Spears, Deputy Director for Regulatory Affairs, CDRH, FDA
Isaac Chang, Division Director, Office of Surveil­lance and Biometrics, CDRH, FDA
Kathleen Cummings, BSN, RN, Product Evaluation Branch II, Division of Post Market Surveillance, Office of Surveillance and Biometrics, CDRH, FDA
Sharon Kapsch, Branch Chief, Reporting Systems, Office of Surveillance and Biometrics, CDRH, FDA
Steven Pollack, Center Director, Office of Science and Engineering Labs, CDRH, FDA (invited)
Eugene Reilly, Public Health Analyst, Information and Analysis Branch, Division of Post Market Surveillance, Office of Surveillance and Biometrics, CDRH, FDA

Industry Speakers

Jay Antonellis, Senior Director, Life Science Practice, Camstar Systems
Mark Brown, Partner, FDA & Life Sciences Practice, King & Spalding; Former Associate Chief Counsel, FDA
Barrett Craner, Vice President, QA/RA, Stellartech Research Corporation
John (Jack) Garvey, Esq., Founder and Principal, Compliance Architects
James Eric Miller, Senior Quality Analyst, Core Quality Systems, Roche Diagnostics
Phil Phillips, President, Phillips Consulting Group; Former Deputy Director, Office of Device Evaluation, CDRH, FDA
Heather Rosecrans, Senior Regulatory Advisor, Greenleaf Health; Former Director of the 510(k) Pre-Market Notification, CDRH, FDA
Dr. Ray Silkaitis, Director Scientific Affairs, Hospira
Jacqueline Torfin, Vice President of Quality, Heraeus Medical Components
Krishna Uppugonduri, Vice President, Quality and Regu­latory Affairs, CareFusion

Pre-Conference Workshop

Writing for Compliance:  Approaches and Methods for Writing High-Impact, Persuasive Compliance-related Documentation within FDA-Regulated Companies

John (Jack) Garvey, Esq., Founder and Principal, Compliance Architects

Despite being one of the most regulated industry sectors in the world, attention to and development of even basic writing practices within most FDA-regulated organizations is almost non-existent.

With extensive requirements for bulletproof communication of complex technical and scientific concepts, and documentation required for almost every operational activity, personnel struggle to write to the appropriate audiences and to choose the proper writing styles and techniques to properly support their day-to-day business objectives.

Even more striking is that many documents are not written with the anticipation and knowledge that an FDA Investigator will likely read them in the future and use these documents as part of the overall determination of the organization’s compliance profile.

Now, John C. (Jack) Garvey, Esq., Founder and Principal of Compliance Architects® has developed an introductory workshop to help participants apply a collection of writing tools to achieve improved compliance outcomes within FDA-regulated companies.  

Based on his experiences from over 25 years within FDA-regulated industry, Mr. Garvey will apply long-established writing principles to common writing challenges within FDA-regulated companies and help participants to understand:

  • The first question you must ask and answer before you engage in a writing activity
  • How to analyze your audience(s) to obtain the proper tone and voice for the writing
  • What one basic writing structure should be applied to all CAPA investigations
  • Which styles are necessary for different document types, including which should be the dominant style and how and where to include other styles
  • What one principle lawyers apply to create powerful persuasive writing regardless of the soundness of their case
  • What is the role of technical information within a document, and how should this information be presented?

In addition, given the importance the FDA places on CAPA, Mr. Garvey will spend considerable time on techniques and approaches for improving the documentation of CAPAs, non-conformances, and other investigation and product analysis events.

About the Conference Co-Chairs

Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration.  He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.  He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. 

Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations.


Elaine Messa is Director of the Medical Device Quality Systems and Compliance Practice at Becker & Associates Consulting, Inc. She has over 30 years of experience in FDA regulation of medical devices, having focused on the development and implementation of compliant Quality Systems for medical devices in the United States. Ms. Messa brings an in-depth and broad knowledge of the compliance and regulatory environment, including the implementation of quality systems, development of corrective action plans, and the management of warning letters. 

Ms. Messa began her career at FDA, where she worked for 30 years. Her most recent position at the Agency was as Director of the Los Angeles District, which is the district responsible for the largest import operations and medical device workload in the US. In total, Ms. Messa spent nearly 16 years in management positions within FDA district offices.

Who Will Benefit

  • Executive management
  • Regulatory affairs
  • Quality Assurance/quality control
  • Research and development
  • Training directors
  • Compliance officers
  • Manufacturing and contracting
  • Release management
  • Consultants/service providers

Date and Location

June 7-9, 2011
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Toll free: (800) 859-8003
Tel: +1 (301) 822-9200
Room rate: $199 single or double (plus 13% tax)
Hotel reservation cutoff date: May 16, 2011

Regular Rate
Complete Congress
(Includes Conference and Workshop)
Conference Only
Pre-conference Workshop Only

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3-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

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Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews 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.