Sixth Annual Medical Device Quality Congress - FDAnews

Sessions include: 

t CDRH’s Compliance Outlook 

t Licensing, Mergers and Acquisitions: Integrating Global Quality Systems Across Global 

Cultures 

t Risk Management for IT Networks Incorporating Medical Devices: IEC 80001-1 — a New 

Standard for Manufacturers and Heath Providers 

t Failure Investigation: Treating the Root Cause and Not the Symptoms 

t US Congressional Regulatory Reform 2009 

t Strategies for Building an Effective Postmarket Surveillance Program 

t Risk Management Panel Discussion — real world, in-the-trenches solutions to today’s 

toughest risk management problems 

t Process Validation Panel Discussion — best practices for updating procedures, retraining 

your employees and assuring you’re in compliance with the new requirements 

Two preconference workshops you won’t want to miss: 

t Supplier Control Case Study: Maintaining Quality and Reducing Risk 

t Implementing Risk Management Systems for Medical Software, IT Networks 

and Usability Standards 

SixtH ANNuAL 

Medical device Quality Congress 

Leading the Way to Better Performance with Quality Systems Compliance 

June 3–5, 2009 • Royal Sonesta Hotel Boston • Cambridge, MA 

early Bird discount 

ends May 1 

With Democratic leadership firmly in control of both the White House and Congress, there are rising voices about 

revamping the FDA. Federal preemption is under attack in Congress — and this could mean big trouble for you. 

Assure your medical device products maintain the highest quality and you’re always in compliance with FDA 

regulations and guidances. With speakers from the FDA, Johnson & Johnson, Covidien, Boston Scientific, GI Dynamics 

and more, you’ll be on top of industry developments. 

The Sixth annual Medical device Quality Congress is the one 

event you must attend in 2009! 

Featured SpeakerS 

Larry Spears, Deputy 

Director for Regulatory Affairs, 

CDRH, FDA 

William Goeller, Director, 

Quality & Compliance, 

Johnson & Johnson 

Sheila Hemeon-Heyer, 

Vice President, Global Regulatory 

Affairs, Boston Scientific 

Karl Vahey, Director of 

Compliance, International RA/QA, 

Covidien 

Steven Niedelman, 

Senior Consultant, 

Crowell & Moring LLP 

Visit www.MDQC09.com or call (888) 838-5578 to register

8:00 a.m.–9:00 a.m. Registration/Breakfast 

9:00 a.m.–12:30 p.m. Supplier Control Case 

Study: Maintaining Quality and Reducing Risk 

Steven Niedelman, Senior Consultant, 


Cathy Burgess, Counsel, 


Medical device manufacturers are becoming increasingly 

dependent on third-party suppliers of raw 

materials, parts, subassemblies and even suppliers 

of original equipment. These suppliers may be situated 

locally, across the country or in a developing country 

halfway around the world. Regardless of where the 

supplier is located, it is essential that the manufacturer 

establish efficient and rigorous supplier control 

programs to assure the quality of the materials and 

products used in finished devices. 

There have been a number of recent high profile press 

reports of recalls, deaths and injuries associated with 

FDA-regulated products. All of these have been the 

result of supplier quality problems. These reports have 

refocused the FDA’s attention on the importance of 

ConferenCe agenDa anD SpeakerS 

The FDA has been under a lot of scrutiny in the last couple months and a new FDA commissioner could usher in radical changes in the 

way it regulates. Two upcoming changes — Class III devices going through the PMA process or being reclassified and the development 

of a Unique Device Identification System — will have medical device firms scrambling to revamp their development and manufacturing 

processes. Chairperson James Wason will lead an impressive line-up of experts who will address the latest industry developments 

and provide the actionable intelligence you need to stay in compliance. 

This is one conference you can’t afford to miss! 

Come early for the preconference workshops! 

Preconference Workshop A: 

Wednesday, June 3, 2009 

“I look forward to this event every year.” 

ensuring that appropriate purchasing controls are in 

place to assure quality. 

Attendees will: 

• Evaluate a case study on supplier quality 

• Assist in developing a risk-based supplier quality 

program based on the case study 

• Determine different ways to assess suppliers based 

upon risk 

• Learn the importance of developing solid contractual 

agreements and change control procedures 

• Understand the importance of supplier quality and 

its relevance to FDA’s quality system requirements 

12:30 p.m.–1:30 p.m. Lunch 

Paul Arrendell, Vice President, Global Quality Systems, Wright Medical Technology, Inc. 

Preconference Workshop B: 

Wednesday, June 3, 2009 

1:30 p.m.–4:30 p.m. Implementing Risk 

Management Systems for Medical Software, IT 

Networks and Usability Standards 

Oliver Christ, CEO, PROSYSTEM AG, International 

Healthcare Consulting, Germany 

Thomas Weber, Regulatory Affairs and 

Risk Management Consultant, PROSYSTEM AG, 

International Healthcare Consulting, Germany 

The effective implementation of a risk management 

system is becoming more cumbersome for medical 

device manufacturers. Manufacturing must take 

into account hundreds of medical device standards 

related to ISO 14971. Examples include; usability of 

medical devices (IEC/ISO 62366), lifecycle processes 

for medical software (IEC/ISO 62304), and the upcoming 

new standard on IT networks incorporating 

medical devices (IEC 80001). 

These emerging standards require risk management 

systems specific to their subject matter but in slightly 

different ways than ISO 14971 envisioned. With 

different references per standard, knowing exactly 

what to do when implementing a risk management 

system becomes increasingly difficult. 


• Learn the key essential aspects of risk management 

required by ISO 14971 

• Understand the difference between hazards, failure 

modes, user errors and harm 

• Determine different ways to set-up acceptability 

criteria 

• Learn how to define clear interfaces between ISO 

14971 and referring standards 

• Understand how to avoid double or triple implementation 

of risk management activities when 

complying with usability or software/hardware 

requirements 

Team Discounts Available! 

Call (888) 838-5578 for details 


Day One 

Thursday, June 4, 2009 


9:00 a.m.–9:15 a.m. Welcome and Introduction 

Chairperson James Wason, Principal, 

Maelor Group 

Update on the FDA’s efforts to issue regulations 

requiring Class III device manufacturers 

to go through the PMA process or have their 

devices reclassified, and the results of the February 12, 

2009, public workshop on the development of a Unique 

Device Identification System. 

9:15 a.m.–9:30 a.m. Update on Massachusetts 

Medical Device Industry 

Thomas Sommer, President, Massachusetts 

Medical Device Industry Council 

Mr. Sommer will examine the current and 

future state of the medical device industry 

and workforce in Massachusetts. 

9:30 a.m.–10:15 a.m. CDRH’s Compliance Outlook 

Larry Spears, Deputy Director 

for Regulatory Affairs, CDRH, FDA 

The FDA issued 123 warning letters 

in 2008 involving devices. Understanding 

the FDA’s approach to them is essential to 

ensuring compliance and avoiding product problems. In 

this session Mr. Spears will take you through the inspectional 

process. 


• Discover the purpose of inspections from CDRH’s point of 

view and CDRH’s inspectional priorities for this year 

• Understand the challenges facing companies and how 

they can more proactively prepare for FDA investigators 

before they arrive 

10:15 a.m.–11:15 a.m. Lessons Learned: How Product 

Failures, Recalls and GMP/QSR Problems Trigger 

FDA Enforcement Actions 

Mark Brown, Partner, King & Spalding LLP 

FDA administrative and judicial enforcement 

actions have increased in the last few years. 

Many companies and corporate officials fail to 

heed important warning signs of impending 

trouble and are surprised when FDA takes enforcement action. 

The consequences can be catastrophic to the company, 

its employees, and its customer base. This session will share 

important lessons learned from actual case studies. 


• Learn the early warning signs of problems in products 

and quality systems 


• Discover what key actions should be taken to contain 

problems and avoid enforcement 

• Understand how to engage in an effective dialogue with 

the FDA to instill its confidence in your company 

• Learn when to seek outside consulting and legal expertise, 

and how they can help 

11:15 a.m.–11:30 a.m. Refreshment Break 

11:30 a.m.–12:15 p.m. Licensing, Mergers and 

Acquisitions: Integrating Global Quality Systems 

Across Global Cultures 

William Goeller, Director, Quality & Compliance, 

Johnson & Johnson 

With companies seeking explosive growth, 

licensing, mergers and acquisitions activity 

continues unabated. Acquiring companies 

face many challenges harmonizing quality systems. Companies 

are faced with integrating quality systems with new 

entities with different geographic and corporate cultures. 

We will look into these challenges and approaches to integrating 

processes, software systems and people into the 

new organization. 

Attendees will discover: 

• When to align or adopt? Real world experiences that 

shape the strategic decisions involving merging quality 

systems 

• How to manage the people part of the puzzle. Is the 

acquired company organized to succeed in the new 

quality system? 

• 5 strategies for integrating software systems 

to enable the quality system compliance to 

function efficiently 

12:15 p.m.–1:00 p.m. Risk Management for IT 

Networks Incorporating Medical Devices: IEC 

80001-1 — a New Standard for Manufacturers 

and Health Providers 

Oliver Christ, CEO, PROSYSTEM AG, International 

Healthcare Consulting, Germany 

Since January 2007 the international Joint 

Working Group No.7 from IEC 62A/ISO TC 215 

has actively worked on the new standard, 

IEC 80001-1. It will become the first IEC standard to address 

manufacturers as well as health providers. If devices from 

different manufacturers are used in one health provider’s IT 

network, IEC 80001 provides a risk management approach 

to manage a safe and compliant collaboration of the parties 

involved. The standard focuses on the aspects of safety, 

effectiveness, data and system security and interoperability. 

It is expected that the standard will become effective by the 

end of 2010. 


• Get a comprehensive review of the requirements of 

IEC 80001-1 

• Analyze key properties of this new standard — and learn 

how they might affect your product development 

• Learn the political impact IEC 80001 may trigger in the 

US and Europe 

1:00 p.m.–2:00 p.m. — Lunch 

2:00 p.m.–2:45 p.m. — Failure Investigation: Treating 

the Root Cause and Not the Symptoms 

Karl Vahey, Director of Compliance, International 

RA/QA, Covidien 

Inadequate failure investigation can result 

in insufficient corrective action and poor 

complaint resolution and ultimately not 

fix the problem. The resulting effect could be 483s and 

warning letters. 


• How to apply good failure investigation strategies — 

and why they are necessary 

• Which failure investigation methods and tools 

are available 

• Lessons learned from applying the results of your failure 

investigation to your CAPA subsystems 

2:45 p.m.–3:30 p.m. — US Congressional Regulatory 

Reform 2009 

Mark Gordon, Vice President, 

Global Regulatory Advocacy and Policy, 

Boston Scientific 

The new political environment in Washington, 

DC, will no doubt result in significant 

change in all sectors, including the regulation of medical 

devices. This session will discuss proposed and passed 

congressional acts that impact the medical device industry. 


• What’s coming down the pipe? Ensuring readiness for 

anticipated new regulations 

• Best steps to prepare for aspects of FDA Globalization Act 

• Emerging elements of FDAAA and how you should be 

positioning your firm 

• Top 5 ways to stay current on emerging regulatory 

reforms 

3:30 p.m.–3:45 p.m. — Refreshment Break 

3:45 p.m.-4:30 p.m. — Managing the Total Product 

Lifecycle: Lowering Costs While Increasing Quality 

Julie Fraser, President, Cambashi, Inc. 

Dan Matlis, President, Axendia, Inc. 

Are medical device companies moving beyond “throwing 

it over the wall” waterfall processes to a more cohesive 

Total Product Lifecycle approach as the FDA proposes? 


For those who have embraced the change, has the move 

to more concurrent and collaborative processes lowered 

costs and increased product quality and safety? How have 

they managed the tranformation from disconnected “silo” 

processes to holistic end-to-end approaches? This session 

will cover these and other related issues based on findings 

and analysis from a research study conducted by Axendia, 

Cambashi, and FDAnews. This research identifies major challenges 

associated with managing the Total Product Lifecycle 

— as well as the transitional issues facing medical device 

organizations and their ecosystem, including outsourcers, 

suppliers, distributors and trading partners. 


• The current state of product lifecycle management in the 

medical device industry 

• How industry leaders are meeting today’s challenges 

• What benefits companies can gain by taking a Total 

Product Lifecycle approach 

• Strategies, best practices and information systems to 

enable this transformation 

4:30 p.m.–5:15 p.m. Training in a QSR Environment: 

Best Practices for Monitoring and Effectiveness 

Betty Lane, President, 

Be Quality Associates LLC 

No one disputes the importance of proper 

training for all employees in a medical device 

company. Yet defining the needs for all 

employees, either individually or by position description, 

can be a real challenge. This is especially true for start-up 

and other small medical device companies. In this best 

practices-focused presentation, understanding the FDA’s 

specific training requirements will be discussed. Plus, 

techniques for needs assessment and recordkeeping. 


• Analyze the types of training requirements and various 

ways to monitor the effectiveness of each 

• Be provided examples of spreadsheets that can be used 

to track training needs and records in one file — these 

are ideal for small and medium sized companies 

• Learn about solutions that can be applied to larger medical 

device companies 

• Take home specific techniques for monitoring and 

documenting training effectiveness 

5:15 p.m.–6:00 p.m. Risk Management 

Panel Discussion 

Moderated by James Wason, Principal, Maelor Group 

Betty Lane, President, Be Quality Associates LLC 

David Jones, Director, Quality Assurance, Regulatory 

Affairs & Philips Business Excellence, Philips Home 

Monitoring 

Pamela Goldstein, Director of Quality Assurance, 

GI Dynamics 


This lively panel will provide real world, in-the-trenches 

solutions to today’s toughest risk management problems. 

It will delve into a practical understanding of risk management 

and risk analysis and analyze how they apply to 

medical devices throughout a product’s life cycle. The panel 

is comprised of medical device and diagnostics industry 

representatives and top industry experts. You will have the 

opportunity to get your toughest questions answered. 

6:00 p.m.–7:00 p.m. Networking Reception 

Day Two 

Friday, June 5, 2009 


9:00 a.m.–9:15 a.m. Welcome and Introduction 

9:15 a.m.–10:00 a.m. Strategies for Building an 

Effective Postmarket Surveillance Program 

Sheila Hemeon-Heyer, Vice President, 

Global Regulatory Affairs, Boston Scientific 

Corporation 

Despite our best efforts, all medical devices 

carry some level of risk. Despite the best 

manufacturing controls, problems can result from errors, 

off-label use and unanticipated risks. Premarket testing is 

conducted under controlled conditions and may not detect 

low-frequency events. Postmarket surveillance systems and 

tools help us meet the goal of assuring continued safety, 

performance and efficacy of marketed products 


• Learn the elements of effective postmarket surveillance 

systems 

• Discover how to build safety in active product controls 

• Learn to maximize the data from postmarket 

device monitoring 

10:00 a.m.–10:45 a.m. Changes to the EU Medical 

Devices Directive: Are You Ready? 

Paul Brooks, Vice President and Country 

Manager, BSI Americas 

This presentation will address the latest 

changes to the EU Medical Device Directive 

and how they will impact the conformity 

assessments being conducted by notified bodies for CE 

marking. The changes include notified body sampling of 

technical documentation, clinical evaluation, labeling and 

essential requirements compliance. All CE marked medical 

device manufacturers are expected to be in full compliance 

with the new requirements by March 21, 2010. 


• Analyze the recent changes to the EU Medical Device 

Directive — what should you be focusing on? 

• Uncover what expectations regulatory bodies have 

for you. 

• Create a compliance game plan you can take back to 

your company 

10:45 a.m.–11:15 a.m. Refreshment Break 

11:15 a.m.–12:30 p.m. Process Validation Panel 

Discussion 

Moderated by James Wason, Principal, Maelor Group 

Vinny Sastri, President, WINNOVIA LLC 

Tracie Capozzio, Quality Assurance & Regulatory Compliance, 

NeuroWave Systems Inc. 

James Schutta, President, S&S Consulting Associates, Inc. 

(Invited) 

As you know, last November the FDA updated its rules 

for process validation for the first time since 1987. It 

will change the way manufacturers have validated their 

processes, written SOPs and trained staff. This interactive 

panel will discuss best practices for updating procedures, 

retraining your employees and assuring you’re in compliance 

with the new requirements. Bring your questions for 

this experienced panel to answer. 

12:30 p.m. Wrap-up and Thanks by Chairperson 

James Wason, Principal, Maelor Group 

WHO SHOULD ATTEND 

• Executive Management 

• Regulatory Affairs 

• Quality Assurance/Quality Control 

• Release Management 

• Training Directors 

• Research and Development 

• Manufacturing and Contracting 

• Compliance Officers 

• Consultants/Service Providers 


ABOUT FDAnews 

FDAnews publishes domestic and international regulatory, legislative and 

business news and information for executives in industries regulated by the 

U.S. Food and Drug Administration. Pharmaceutical and medical device 

professionals rely on FDAnews’ print and electronic newsletters, books, 

management reports and conferences to stay in compliance with international 

standards and the FDA’s complex and ever-changing regulations to get their 

products to market faster and boost profits. FDAnews brings you the knowledge 

you need, when you need it. 

ABOUT ThE CONFErENCE ChAIrPErSON 

James Wason, Chairperson, Principal, Maelor Group, Amherst, NH 

James Wason is a recognized leader with a successful track record. He is a 

sought-after speaker and presenter at medical device industry trade groups 

and conferences, and has more than 25 years of senior management experience 

in the medical device industry. He was the executive vice president of 

Medical Device Consultants, Inc., a full-service CRO and regulatory consulting 

firm. He oversaw and contributed to more than 250 client projects to 

design and implement strategies for FDA and international authorization of 

novel and innovative medical devices. He held senior management positions 

with C.R. Bard, Johnson & Johnson, and Cambridge Scientific Instruments, 

Ltd., overseeing business development, product management and product 

development activities. He holds a Ph.D. in Biomedical Engineering and a B.S. 

in Mechanical Engineering from the University of Surrey, UK. 

LOCATIONS AND hOTEL ACCOMODATIONS 

To reserve your room, call the hotel at the number below. Be sure to tell the 

hotel that you’re with the FDAnews Sixth Annual Medical Device Quality 

Congress conference to qualify for the reduced rate. Only reservations 

made by the reservation cutoff date are offered the special rate, and space is 

limited. The hotel may run out of rooms before the reservation cutoff date. 

The discounted rate is also available one night before and after the event based 

(Please see “Team Discounts” above for tuition discounts when you send a team of three or more.) 

Attendee 1: Name Title Email 

Attendee 2: Name Title Email 

Email address (so you can receive order acknowledgements, updated news, product information and special offers) 

Company Address 

City State ZIP Country 

Phone Fax 

Payment Options 

Check enclosed, payable in U.S. funds to FDAnews 

Please bill my company $ Purchase order # 

(Payment is required by the date of the conference.) 

SixtH AnnuAl 

Medical Device Quality Congress 



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on availability. The hotel may require the first night’s room deposit with tax. 

Room cancellations within 24 hours of the date of arrival or “no-shows” will 

be charged for the first night’s room rate plus tax. 

Royal Sonesta Hotel Boston 

40 Edwin Land Boulevard 

Cambridge, MA 02142 

Toll free: (800) SONESTA • Tel: +1 (617) 806-4200 

www.sonesta.com/boston 

Room rate: $249 single or double (plus 12.45 percent tax) 

Hotel reservation cutoff date: May 12, 2009 

CANCELLATIONS/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. 

TEAM DISCOUNTS 

Significant tuition discounts are available for teams of three or more from the 

same company. You must register at the same time and provide a single payment 

to take advantage of the discount. Call +1 (703) 538-7600 for details. 

ExhIBITOr INFOrMATION 

Exhibit locations and sponsorship packages are still available. For details, 

contact Andrew McSherry of FDAnews at +1 (703) 538-7643 or email 

amcsherry@fdanews.com. 

Yes! Please enroll me in the Sixth Annual Medical Device Quality Congress, for the option I’ve selected below. 

Complete Congress 

(Includes: Congress and both 

Workshops) 

Early Bird Fee Until 

May 1, 2009 

No. of 

Attendees 

Fee From 

May 2–June 3, 2009 

$1,967.00 $2,297.00 

Conference and one Workshop $1,777.00 $2,097.00 

Conference Only $1,627.00 $1,897.00 

Both Workshops $997.00 $1,257.00 

One Workshop $537.00 $697.00 

TOTAL PAYMENT $ $ 

No. of 

Attendees 

Online: 

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Phone: 

Mail: 

FOUR EASY WAYS TO REGISTER 

www.mdqc09.com 

+1 (703) 538-7676 

Toll free (888) 838-5578 (inside the U.S.) 

or +1 (703) 538-7600 

FDAnews, 300 N. Washington St., Suite 200 

Falls Church, VA 22046-3431 U.S.A. 

Priority Code: Brochu 

300 N. Washington St., Suite 200 

Falls Church, VA 22046-3431

300 N. Washington St., Suite 200 

Falls Church, VA 22046-3431 U.S.A. 

SixtH ANNUAl 

Medical Device Quality Congress 



PRESORt 

FiRSt ClASS 

U.S. POStAGE 

PAiD 

PERMit NO. 1906 

SOUtHERN MD 

“I really enjoyed this conference. I will definitely 

recommend this for co-workers next year!” 

Nancy LaRoche, QS Manager, DEKA Research and Development 

Elite experts in the field present cutting-edge knowledge on design control, postmarket surveillance, complaint reporting, 

inspections, software validation, harmonization and contractor quality assurance. 

“Impressive panel of industry and regulatory experts.” 

Michele McDonald, Senior Compliance Auditor, Abbott Inc. 

“It was great to have such knowledgeable 

personnel available for three days to ask questions 

and have discussions.” 

Diane Adinolfo, QA Project Compliance Manager, DEKA Research and Development 

www.MDQC09.com

Sixth Annual Medical Device Quality Congress - FDAnews

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