MDQC 2011 Agenda



8:00 a.m. – 9:00 a.m.

Registration and Continential Breakfast

9:00 a.m. – 12:00 p.m.

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

Despite being one of the most regulated industry sectors in the world, attention to and develop-ment of even basic writing practices within most FDA-regulated organizations is almost nonexis-tent. With extensive requirements for bulletproof communication of complex technical and scien-tific concepts, and documentation required for almost every operational activity, highly technical personnel struggle to write to the appropriate audiences, and to choose the proper writing styles and techniques to effectively support their day-to-day business objectives. Even more striking is that many documents are never written with the anticipation and knowledge that an FDA inspector will likely read them in the future and use these documents as part of the overall deter-mination 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 experi-ences of more than 25 years within the industry, Mr. Garvey will apply long-established writing principles to common writing challenges within FDA-regulated companies and help participants 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
  • The role of technical information within a document, and how this information should be presented

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

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


12:00 p.m. – 1:00 p.m.


1:00 p.m. – 1:15 p.m.

Welcome and Introduction by Co-chair Steven Niedelman

1:15 p.m. – 2:00 p.m.

Opening Keynote:  Supplier Controls — FDA Medical Device Requirements
The FDA has been actively focusing on the protection and integrity of supply chain for medical devices. Understand­ing the FDA’s approach is essential to ensuring compli­ance and avoiding inspection issues. In this session Kimberly Trautman will take you through the latest FDA policies and processes.

Attendees will learn:

  • Common supplier issues the FDA uncovers in medical device inspections and how can firms avoid them
  • How suppliers, contractors and consultants should meet the requirements established by the finished device manufacturer
  • After the initial assessment or evaluation, determine the combination of assessment methods, and how to include third party or product certification

Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA

2:00 p.m. – 2:45 p.m.

Managing Global Risk Management Programs To Assure User Needs Are Met
The importance of risk management in assuring medical devices meet user needs cannot be overstated.  Rick man­agement is a multi-faceted process that involves building the proper teams, implementing effective organizational structures and training and developing comprehensive surveillance systems.  In addition, global firms must as­sure their risk management programs are effective within each regulatory regime in which they operate.

Attendees will learn:

  • Best practices for building, training and deploying risk management teams
  • Tips for complying with international regulatory regimes
  • Assuring surveillance systems work

Dr. Ray Silkaitis, Director Scientific Affairs, Hospira

2:45 p.m. – 3:00 p.m.

Refreshment Break

3:00 p.m. – 3:45 p.m.

Utilizing Risk Assessment to Manage OEM/Contract Suppliers
Managing OEM/Contract suppliers can drain resources, especially with the recent scrutiny and emphasis on ensuring that manufacturers truly understand and control their contract deliverables. By using your current quality systems, common sense and risk principles, you can ensure that the right amount of control is exercised over these key supply-chain partners. This approach can be used in conjunction with or in lieu of the quality portion of a “supplier scorecard” system.

Attendees will learn:

  • How to incorporate elements of supplier manage­ment into current quality systems
  • Proven ways to implement risk assessment principles to improve supplier management
  • Case studies of risk-based supplier management

Jacqueline Torfin, Vice President of Quality, Heraeus Medical Components

3:45 p.m. – 4:30 p.m.

Detecting, Controlling and Prevent­ing Quality Problems — Best Practices for Advancing Product Quality Across Extended Supply Chains
Global manufacturers wrestle daily with optimizing and leveraging the cost advantages of global supply networks while ensuring product quality to protect their products and patients.  From small, single component suppliers to large OEMs, device makers needs to assure that products adhere to quality specifications.  This presenta­tion will teach firms how they can predict quality — and analyze incidents — from internal supply chains and external suppliers.

Attendees will learn:

  • Characteristics of a closed-loop approach that enables proactive business decisions — resulting in higher product quality, growth and profitability
  • How global medical device companies drive continu­ous improvement in their complex global manufactur­ing and outsourced processes  and quality systems
  • Industry benchmarks that show positive business results of embracing a closed-loop approach to product quality.

Jay Antonellis, Senior Director, Life Science Practice, Camstar Systems

4:30 p.m. – 6:00 p.m.

Panel Discussion: How eMDR Will Change Quality Management and Reporting Responsi­bilities
In August 2009, the FDA proposed a rule requiring that device manufacturers submit all medical device reports (MDRs) electronically, making formal an option that has been available for a few years.  But what’s the latest on the rule and the FDA’s expectations for device firms?  Some firms have wondered about the costs and the timeline for complying with the requirements.  Others are interesting in knowing how the FDA uses the data and guidance on integrating eMDRs into their postmarket surveillance operations.

What better way than go straight to the source?  FDAnews has convened top officials from CDRH’s Office of Surveillance and Biometrics to provide the latest updates and answer the tough questions.

Moderator: Elaine Messa, Director, Medical Device Quality Systems and Compliance Practice,  Becker & Associates Consulting, Inc


  • Isaac Chang, Division Director, Office of Surveil­lance and Biometrics, CDRH, FDA
  • Sharon Kapsch, Branch Chief, Reporting Systems ­lance, 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
  • Eugene Reilly, Public Health Analyst, Information and Analysis Branch, Division of Post Market Surveillance, Office of Surveillance and Biometrics, CDRH, FDA

6:00 p.m.



8:00 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 9:15 a.m.

Welcome and Introduction by Co-chair Elaine Messa

9:15 a.m. – 10:15 a.m.

FDA Update on How Science Shapes the Agency’s Regulatory Decision-making
The Office of Science and Engineering Laboratories (OSEL), one of seven Offices within CDRH, contributes to the Center’s mission by providing laboratory data and consults. OSEL serves as the laboratory science nucleus for the Center. Specifically, OSEL supports the scientific basis for the Agency’s regulatory decision- making by developing independent laboratory information for regu­latory and other public health activities of CDRH.

Attendees will learn:

  • How the OSEL interacts with other divisions
  • What the FDA is looking for with regards to your scientific data and lab work
  • The latest advances OSEL is making in risk assess­ments, forensic investigations, product evaluations, and technology assessment

Steven Pollack, Center Director, Office of Science and Engineering Labs, CDRH, FDA (invited)

10:15 a.m. – 11:00 a.m.

Applying Risk Management in a Straightforward Manner — Utilizing a Single, Closed Loop Flowsheet for Product Review
No medical device is entirely free of risk but there’s wrong ways and right ways to minimize risk?  ISO 14971, the international standard in device risk management, can significantly help create a solid risk management plan. But understanding the expanded ISO and effectively implementing it is not the same thing. This presentation will help large and small firms to discover and use the best risk management tools.

Attendees will learn:

  • How to apply risk management in a straightforward manner — utilizing a single, closed loop flowsheet to allow QA professionals to objectively review a product for risk
  • 5 of the best tools to apply in a good risk manage­ment program
  • Tips on creating and tracking mitigations (pretest/startup testing, runtime testing, independent testing, and RAM testing)

Barrett Craner, Vice President, QA/RA, Stellartech Research Corporation

11:00 a.m. – 11:15 a.m.

Refreshment Break

11:15 a.m. – 12:00 p.m.

Trending QSR Data: Requirements and Best Practices for Devicemakers
Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems.  You are now expected to trend your quality data.  In fact, the FDA wants you to maintain a 24/7 state of control by proactively monitoring your quality systems.  And compliance isn’t optional, despite the fact that your information sits isolated in “data silos” like complaints and OOS — making your task of identify­ing trends nearly impossible.

Attendees will learn:

  • Best practices to master a troubling regulatory standard
  • Sources of quality data, including minimums, and offers suggestions for company-specific measures
  • The latest in principal trending and statistical methodologies
  • Tried-and-tested reporting tools, dashboards and management review techniques

James Eric Miller, Senior Quality Analyst, Core Quality Systems, Roche Diagnostics

12:00 p.m. – 12:45 p.m.

Integrating End Use Communities into Device Design Workflow
Manufacturers need to be open to extending collabora­tion with clinicians and other end use communities during device design.  Typically, the industry collaborates with clinicians and hospitals primarily on gathering informa­tion when there is an issue.  The task is to collaborate beyond when there is an issue — collaboration should begin early in the design phase.  Creating a better set of workflows will improve device design quality and reduce concerns once devices are in the field.

Attendees will learn:

  • How to indentify and start collaborating with end user communities
  • Best practices for developing workflows that provide device makers with usable information and insights
  • Examples of how the collaborative process leads to quality improvement and reduced field concerns

Krishna Uppugonduri, Vice President, Quality and Regu­latory Affairs, CareFusion

12:45 p.m. – 2:00 p.m.


2:00 p.m. – 2:15 p.m.

Morning Recap by Co-chair Elaine Messa

2:15 p.m. – 3:00 p.m.

CDRH’s Compliance and Enforce­ment Outlook
This presentation will focus on CDRH’s inspectional priorities for the coming year and how the center ap­proaches the inspectional process. Larry Spears, FDA’s Deputy Director for Regulatory Affairs, will educate attendees on how they can more proactively prepare for FDA investigators before they arrive.

Attendees will learn:

  • What were the commonalities in the warning letters CDRH issued in recent years
  • 7 tips for better post-inspection correspondence
  • When should you ask for a post-inspection meeting
  • How are inspections classifications (NAI, VAI, OAI) determined

Larry Spears, Deputy Director for Regulatory Affairs, CDRH, FDA

3:00 p.m. – 3:45 p.m.

Best Practices in FDA 483 and Warn­ing Letter Management and Recovery
In the current enforcement environment, outlined by FDA Commissioner Dr. Margaret Hamburg, the Agency expects responses to Form 483s and warning letters within 15 business days.  Preparing comprehensive, persuasive responses to FDA's findings are critical to a company's success in regaining a positive compliance profile.  Responses must incorporate well-designed and well-written corrective action plans that will convey a commitment for effective and sustaining compliance.

Attendees will learn:

  • How to manage Form 483s and warning letters including recovery from financial and competitor impact
  • Best practices in preparing a response that meets FDA's expectations
  • Understanding your audience when writing your response
  • Whether an effective response to an Form 483 can avert a warning letter

Elaine Messa, Director, Medical Device Quality Systems and Compliance Practice, Becker & Associates Consult­ing, Inc.

3:45 p.m. – 4:00 p.m.

Refreshment Break

4:00 p.m. – 6:00 p.m.

Panel Discussion: The 510K Overhaul and What it Means for Quality Professionals
In January the FDA announced changes to the 510(K) pro­gram.  It outlined 25 suggestions it will begin implement­ing as early as March, but it said it will refer the proposals that drew “significant concern” in public comments to the Institute of Medicine (IOM), which is working on an inde­pendent review of the clearance process.  The IOM will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health.

This panel of experts — including high profile former FDA officials — will dissect the coming changes and discuss and debate how they will affect the quality departments and operations of device and diagnostic manufacturers.  Panelists will also discuss how the pending IOM report on the more significant concerns could require more dramatic changes in quality management systems.

Moderator: Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding


  • Phil Phillips, President, Phillips Consulting Group; Former Deputy Director, Office of Device Evaluation, CDRH, FDA
  • Dr. Ray Silkaitis, Director Scientific Affairs, Hospira
  • Heather Rosecrans, Senior Regulatory Advisor, Greenleaf Health; Former Director of the 510(k) Pre-Market Notification, CDRH, FDA
  • Marjorie Shulman, Acting Director, Premarket Notification (510(k)), Office of Device Evaluation, CDRH, FDA

6:00 p.m. – 7:30 p.m.

Adjournment and Networking Reception


8:00 a.m. – 9:00 a.m

Continental Breakfast

9:00 a.m. – 9:15 a.m.

Welcome and Introduction by Co-chair Steven Niedelman

9:15 a.m. – 10:00 a.m.

FDA Postmarket Surveillance Program: Where we have been… where we are going?
The Division of Postmarket Surveillance (DPS) within CDRH is responsible for the collection, analysis, and dissemination of postmarket surveillance data on medical and radiation-emitting devices throughout the FDA. Over the past decade, it has evolved with the changing regulatory landscape. This session presents a historical overview and a peek into how FDA is modernizing its postmarket surveillance program.

Attendees will learn:

  • How the Division of Postmarket Surveillance is work­ing to improve device postmarket performance
  • What the FDA looks for in a postmarket surveillance program
  • Best practices for improved signal detection

Isaac Chang, Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH, FDA

10:00 a.m. – 10:45 p.m.

Recall Management: Analyzing Recent High-Profile Recalls and Lessons Learned
Recent high-profile device recalls have focused attention on maintaining device quality management, monitoring products once they hit the market and reacting quickly and professionally if problems develop. The FDA is ac­tively evaluating policy changes in response to calls from patients, Congress and other interested parties about how to assure that products that develop problems are properly removed from the market.

Attendees will learn:

  • Lessons from recent recalls
  • What factors the FDA takes into account when determining a recall classification
  • Best practices to assure each department within your firm is on the same page regarding your recall policy

Mark Brown, Partner, FDA & Life Sciences Practice, King & Spalding; Former Associate Chief Counsel, FDA

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 11:45 a.m.

Closing Keynote: CDRH's Business Case for Compliance
CDRH has evaluated the barriers to adopting best quality practices that industry faces, as well as steps that FDA can take to promote adoption of these practices. Steven Silverman will present a business case addressing how manufacturers that integrate best quality practices, organization-wide, realize benefits that are unavailable to competitors who drive quality via a more traditional, centralized model.

Attendees will learn:

  • How organization wide compliance strategies can improve adherence to quality regulations
  • How best-in-class quality strategies lead to a more competitive company
  • Why centralized quality management lends itself to compliance violations

Steven Silverman, Director, Office of Compliance, CDRH, FDA

11:45 a.m. – 12:00 p.m.

Closing Comments by Co-chairs Steven Niedelman and Elaine Messa

12:00 p.m.

Conference Adjournment