MDQC 2010 Agenda

Updated on May 27, 2010


12:00 p.m. – 1:00 p.m.


1:00 p.m. – 4:30 p.m.

Pre-conference: Reducing Human Error on the Manufacturing Floor

This workshop will teach attendees how to implement proven and measurably-successful human reliability and error reduction initiatives. Attendees will learn how to influence human factors to assure CAPA compliance and reduce errors. Dr. Ginette Collazo will also reveal tips and tricks for writing accurate job descriptions, innovative hiring practices and how to develop great SOPs.

Human error is still one of the most commonly cited causes of failures and recalls. The vast majority of CAPA investigations conclude with some kind of human error as the root cause. Dr. Collazo will share more than 10 years of in-depth research and experiences helping medical product firms reduce errors by up to 50%.

Dr. Collazo will detail her strategies for determining the scope of problems by employing four best practices:

  • Diagnosis — How to re-analyze failure investigations for the last 12 months
  • Categorize and Code — Sorting investigation results into four levels
  • Quantify — Determining what level to tackle first
  • Plan Based On Priorities — Giving yourself a GUT check, how to use Gravity, Urgency and Tendency (GUT) to set your training priorities

Additionally, attendees will learn how to deploy a five point method to expand the scope of their training efforts. This method includes:

  • Changing the focus of training from learning to reliability
  • How to constantly challenge your training methods
  • Creating interdisciplinary groups to tackle training problems
  • Improving specific training — human behavior, instructions development, training methods, investigation processes
  • Enhancing the depth and breath of courses and skills taught to managers and employees

Workshop Instructor: Dr. Ginette Collazo, Founder and CEO, Ginette M. Collazo Inc.


8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 9:15 a.m.

Welcome and Introduction by Chairperson Barry Craner, Principal, CQA-Associates Consulting

9:15 a.m. – 10:15 a.m.

Keynote: CDRH Outlook
This is your chance to hear what the FDA is doing and is planning to do in 2010 and beyond. Dr. Sackner-Bernstein will share the Center’s strategic priorities for this year and ideas for how companies can proactively prepare. Understanding the FDA’s approach to public health is essential to ensuring compliance and avoiding product problems. In this session Dr. Sackner-Bernstein will take you through the new process and initiatives CDRH is pursuing.

Dr. Jonathan Sackner-Bernstein, Associate Director, Postmarket Operations, CDRH, FDA

10:15 a.m. – 11:00 a.m.

Minimizing the Risk in Risk Management: Understanding and Living ISO 14971:2009
Recently, more emphasis on “risk-based” processes is expected, such as risk-based product and process designs and risk-based inspections. Not only are notified bodies interested and now scrutinizing such processes, but also internal and corporate auditors, and the FDA are becoming interested in your risk management systems. What we need are efficient, compliant and systemic risk management systems that give us real value.

Attendees will learn:

  • How to create risk management systems, including risk management files
  • What tools can be used to analyze risk from products, processes, and how to report them
  • When to use the various risk management tools, such as hazards analysis, failure modes and effects analysis, fault tree analysis, hazards and critical control point analysis, and other risk management tools

Barry Craner, Principal, CQA-Associates Consulting

11:00 a.m. – 11:15 a.m.

Refreshment Break

11:15 a.m. – 12:15 p.m.

CDRH Update on Design Control: Improving Quality Assurance and Engineering Principles
Design control is one of the industries biggest obstacles that repeatedly troubles device firms. In this presentation you will hear what the FDA’s major areas of concern are. This session will discuss the importance of design and development planning, design input and output, design verification and validation, and design transfer and changes. Also, recent trends in warning letters citing design control deficiencies will be used as examples.

Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA

12:15 p.m. – 1:00 p.m.

Tools for Efficient Design Control: Best Practices for Lowering Costs and Improving Schedules While Remaining Compliant
Throughout the design control process there are opportunities to improve efficiency through technology.  Personnel involved in product development, manufacturing, quality assurance, and regulatory affairs all have a stake in the design control process and there are tools available for every design control phase.  At the same time, 21 CFR Part 11 governs how electronic records and signatures are handled, so we need to choose our technology tools carefully.

Attendees will learn:

  • How specific technologies can be used as various stages of the design control process
  • When 21 CFR Part 11 applies, and how to validate OTS software for design controls
  • What tools are actually being used in the industry, and how these systems hold-up during an audit

Brad Ryba, Senior Manager, Quality Engineering Labs, Philips Healthcare

1:00 p.m. – 2:00 p.m.

Lunch Break

2:00 p.m. – 3:00 p.m.

Understanding Internal and External Supplier Relationships
Effective management of suppliers on a global scale continues to be a growing challenge as offshore sourcing continues to rise. Key issues include: an overall outsourcing plan and identification of the critical ties back to your overall quality system that will impact your business. This session will explore the characteristics of an effective quality system and how to deal with the internal and external supplier issues.

Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA

3:00 p.m. – 3:45 p.m.

Forget About Controlling Your Suppliers: You Can't
The industry's recent rash of supplier-driven recalls and health hazards is putting the spotlight on how medical device manufacturers can assure that their raw materials and service suppliers are not only adequate, but safe. For some organizations, ensuring safety means exerting more control over their vendors. Not only is such an approach doomed to failure, but it is not the most efficient way to ensure that you get what you expect from your suppliers.

Attendees will learn:

  • Why vendor audits are not enough to assure supplier quality
  • Why more control of your vendors is not going to help
  • How to develop stronger relationships with your vendors to protect both of you

Jay Wigley, Director of Quality, Contract Medical Manufacturing, Team Technologies

3:45 p.m. – 4:00 p.m.

Refreshment Break

4:00 p.m. – 5:15 p.m.

Interactive Panel: Creating a Supplier Agreement
An interactive panel, led by Jim Shore, Principal Quality Engineer at Boston Scientific, will discuss how to create and maintain a supplier agreement. Using actual work-related examples, this discussion will allow attendees to participate in creating unique Supplier Agreements and share best practices. This discussion will allow attendees to toss out their toughest supplier problems and our panelists and the audience will work up a quick solution.


  • Barry Craner, Principal, CQA-Associates Consulting
  • Dan O'Leary, Consultant, Ombu Enterprises

5:15 p.m. – 6:15 p.m.

Adjournment and Networking Reception


8:00 a.m. – 8:45 a.m.

Continental Breakfast

8:45 a.m. – 9:00 a.m.

Welcome and Introduction by Chairperson Ed Bills, Principal Consultant, Bilanx Consulting LLC

9:00 a.m. – 9:45 a.m.

Managing Operations Effectively: Deliver Quality Devices and  Always Be Audit Ready
As the FDA’s field staff continues to grow, that long overdue inspection is more likely than ever to occur. In alignment with Dr. Hamburg’s presentation on enforcement in August 2009, FDA will be prepared to effectively follow-up and act on potentially volatile situations to reassure the public that they are providing the public health protection they expect
and deserve.

Attendees will learn:

  • 5 key elements to have in place to control your manufacturing processes
  • How to build an effective CAPA system to take corrective action quickly when a problem arises
  • How to create an effective listening system to know how your product is performing and the steps to take when something goes awry

Steven Niedelman, Senior Consultant, Crowell & Moring LLP

9:45 a.m. – 10:30 a.m.

Medical Device Recalls: Unique Challenges and Opportunities
No company enjoys conducting recalls and most view them as a necessary evil. Done efficiently and effectively, however, even a product problem can give your company an opportunity to demonstrate high quality standards and concern for customers. A well-developed and tested methodology for conducting recalls is an important first step.

Attendees will learn:

  • The best ways to turn a problem into a unique opportunity
  • A successful and efficient model for recall decision-making that will satisfy the FDA
  • How to assure the effectiveness of recalls — three steps to make it happen quickly

Patricia Shrader, Senior Vice President, Corporate Regulatory and External Affairs, Becton Dickinson

10:30 a.m. – 10:45 a.m.

Refreshment Break

10:45 a.m. – 11:30 a.m.

Closing the Loop on Corrective and Preventive Action (CAPA): A Call to Action
CAPA problems continue to be one of the most cited FDA Form 483 deficiencies generating the single largest number of warning letter citations. This session will discuss the importance, requirements, and elements of a best in class CAPA program, as well as describing how to use CAPA data to help mitigate risk and drive quality in a holistic manner.

Attendees will learn:

  • New and updated regulatory requirements and expectations – including GHTF quality ystems and CAPA guidance
  • How to implement a repeatable, standardized, and complete process that can tackle CAPAs and ensure compliance
  • The importance of developing closed-loop systems that detect existing potential quality problems and facilitate rapid problem resolution and closure

Nancy Duarte-Lonnroth, Director, Quality & Compliance, Healthcare, Celestica

11:30 a.m. – 12:15 p.m.

Beyond Compliance: Advancing Product Quality and Delivering Business Value

Manufacturers that adopt a closed-loop approach to product quality – rather than maintaining their traditional compliance-focused processes – are able to drive business value from: good quality processes, early detection and prevention of issues, the visibility to quickly find and correct root causes, and enforcement to drive consistency across all plants.

Attendees will learn:

  • How Terumo’s strategy drives continuous improvement in its complex global manufacturing processes and quality systems
  • How to turn FDA regulations into an impetus for proactive business decisions that enable higher product quality, growth and profitability
  • Industry benchmarks that show positive business results of embracing a closed-loop approach
Mark Lincoln, Vice President of Operations, Terumo Cardio Vascular Systems
Karim Lokas, Vice President of Product Strategy, Camstar Systems, Inc.

12:15 p.m. – 1:15 p.m.

Lunch Break

1:15 p.m. – 2:00 p.m.

Japan and China Quality Management Systems
Quality systems are a key issue in Japan's medical markets. Riskier devices now require quality management system audits for product registration in Japan. Japanese quality requirements are often more stringent than the FDA. Many of these Japanese quality standards and regulations have different names and content from similar Western standards. Case studies will be used to emphasize key points.

Attendees will learn:

  • How to prepare for a Japanese QMS audit
  • Which documents are required
  • Best strategies to be successful for a Japanese QMS audit
  • What are the new GMP regulations in China
  • How you can get your Chinese supplier to improve quality
Ames Gross, President and Founder, Pacific Bridge Medical

2:00 p.m. – 2:45 p.m.

CDRH's Signal Detection and Escalation Program
CDRH’s goal is to fully implement a business process for signal detection and escalation by the end of 2010. Ms. Moynahan will describe the details of the new program that includes training staff, tracking and trending, and prioritizing signals. She will also describe how this may impact your responsibility to understand and respond to changing expectations in order to ensure patient safety of a device and supporting premarket calculations.

Megan Moynahan, Network Leader on the Cardiac Electrophysiology Network, CDRH, FDA

2:45 p.m. – 3:30 p.m.

Understanding Medical Device Reports Under 21 CFR Part 803
The FDA has laid out guidelines device firms must follow in 21 CFR Part 803 that detail steps to take when filing a medical device report. Firms have many responsibilities that involve the patient, the user facilities, and their importers. Not only are you required to file medical device reports, but you must also submit any follow up information on each.

Attendees will learn:

  • What key terms, definitions and forms that firms are responsible for
  • The difference between 5 day reports and 30 day reports — Which one to use and when
  • Who is qualified to make medical judgments 21 CFR 803.20(c)(2)

Allen Tabor, Manager, Quality Systems, Zimmer Spine

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 4:30 p.m.

Closing Panel: Lessons Learned & Wrap Up
In this interactive panel discussion, there will be no PowerPoint presentations — just a review of the event’s highlights and what can be taken away and put into practice upon return. The chairpersons, panelists and attendees will attend to any stones that were left unturned and describe the ideas or strategies they most found helpful and plan to bring back to their companies.


  • Ed Bills, Principal Consultant, Bilanx Consulting LLC
  • Steven Niedelman, Senior Consultant, Crowell & Moring LLP
  • Mark Brown, Partner, King & Spalding
  • Dan O'Leary, Consultant, Ombu Enterprises