MDQC 2012 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 development of even basic writing practices within most FDA-regulated organizations is almost nonexistent. With extensive requirements for bulletproof communication of complex technical and scientific 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 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 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 single 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 single 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, Mr. Garvey 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


1:00 p.m. – 1:15 p.m.

Welcome and Introduction by Co-chair Steven Niedelman

1:15 p.m. – 2:00 p.m.

Keynote: New International Medical Device Regulators Forum (IMDRF)
The International Medical Device Regulators Forum (IMDRF) is a forum to discuss future directions in medical device regulatory harmonization. A voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF). IMDRF will accelerate international medical device regulatory harmonization and convergence. Ms. Trautman will discuss the latest developments of the forum and what we can expect.

Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, CDRH, FDA

2:00 p.m. – 2:45 p.m.

Best Practices in Implementing an Effective Risk Management System
As technologies and innovation push the boundaries for new medical devices, there is an increased emphasis and expectation that such devices shall be free from unacceptable risk to the patient and end-user. In addition, several recent standards and guidance documents point to ISO 14971:2007 as the standard for medical device risk management. An effective risk management strategy has thus become a necessity for medical device manufacturers.

Attendees will learn:

  • Organizational factors that lead to an effective risk management system
  • How companies integrate their product life-cycle processes with risk management
  • What constitutes an effective risk management file
  • Methods companies use to review, validate and improve their risk management systems

Dr. Vinny Sastri, President, Winovia LLC

2:45 p.m. – 3:00 p.m.

Refreshment Break

3:00 p.m. – 3:45 p.m.

Managing Risk in the Supply Chain
The FDA’s Quality System Regulation and GHTF guidance require manufacturers to maintain strong supplier oversight and purchasing controls not only for regulatory compliance but also as part of their liability risk management strategy. Supply chain issues are a common source of costly field actions, adverse publicity and product liability suits, yet sometimes suppliers fail to offer the level of transparency and quality control that medical device companies need. Using case studies and actual data on product problems, legal claims and monetary awards, this presentation will show you best practices for managing product liability risk in your own supply chain.

Attendees will learn:

  • Who is legally responsible in a manufacturer-supplier relationship for a product's liability
  • How product liability affects the life sciences field
  • Where vulnerabilities lie in the manufacturer-supplier relationship
  • Early warning signs of impending supplier problems
  • The nature and volume of medical device product liability claims related to supplier issues
  • Best practices to help manufacturers better manage liability risk in the supply chain

Sara Dyson, Assistant Vice President of Loss Control, Medmarc Insurance Group

3:45 p.m. – 4:30 p.m.

Update on FDA’s Pathway to Global Product Safety and Quality Initiative
Deputy Commissioner for Globalization and Regulatory Operations, Ms. Deborah Autor, will discuss the agency's pathway to global product safety and quality. With emerging new challenges and a four-fold increase in the volume of FDA-regulated imports from just a decade ago and an expectation for continuing increases, FDA leadership developed the Pathway to Global Product Safety and Quality to position the agency to meet these emerging challenges. Following the presentation, time will be allocated for an interactive question-and-answer session with Ms. Autor.

Attendees will learn:

  • Updates on the Pathway to Global Product Safety and Quality initiative
  • Understanding the FDA's approach and expectations
  • Recognizing opportunities where the industry itself can be proactive in securing their supply chain and promoting global product safety and quality

Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, OC, FDA (invited)

4:30 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. – 10:00 a.m.

Keynote:  CDRH's Business Case Quality Initiative
Simply reviewing and explaining often-cited 483 violations is the wrong way to achieve device quality. Steven Silverman will present the OC’s current initiatives that are underway that move beyond the inspect-and-cite regulatory model.

Attendees will learn:

  • How a business case for quality imitative collaboratively works
  • Other initiatives that similarly focus on product quality outcomes

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

10:00 a.m. – 10:45 a.m.

Case Study — Reducing Product Review Times and Steps to Ensure Smoother Global Approvals
It is now common in regulatory agencies worldwide to have a mix of experienced and novice reviewers, with different levels of technology understanding and interpretation of the regulations.  Over the past four years, Cochlear has learned a wealth of best practices it uses to make it easier for regulators to understand its products and application documentation.  In this insightful presentation, Cochlear will share some of its practical solutions to reduce review times and facilitate smoother approvals.

Attendees will learn:

  • That taking ownership of review times and the ease of reviews is more effective than blaming regulatory agencies
  • Easy examples on how to structure a submission and its documents, making it more manageable for regulatory reviewers
  • The value of transforming competent engineers into competent document authors and how to achieve it
  • How to balance quasi-harmonized requirements and local expectations in a regulatory submission
  • How to implement submission and document quality in the product development process

Manuel Urena, Regulatory Affairs Manager, ResMed Ltd

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 11:45 a.m.

The FDA's Seldom-Used Corporate Warning Letter — The Journey Back
Unlike a warning letter, a corporate warning letter is aimed at all facilities within the corporation, including the corporate headquarters.  In 2007, Teleflex received a corporate warning letter from the FDA, and in 2011 they received a resolution letter.  Theirs was a journey of understanding the issues outlined in the corporate warning letter, understanding why past efforts had failed, establishing a clear plan for rebuilding the quality system, communicating progress to the FDA, preparing for re-audits, enduring the re-audits, and then working for a final resolution.  As the FDA increases pressure on industry, the corporate warning letter is a seldom-used but powerful tool that they have to gain compliance.

Attendees will learn:

  • Learn about corporate warning letters and the significance to the company from a financial perspective
  • Understand a path that can be taken to improve compliance and elevate the quality system
  • Learn how to involve the critical members of senior management and how they can influence the compliance culture
  • Learn the importance of audit preparation and execution
  • Strategies for making the quality system work at all levels

Michael Crader, Vice President, Global Regulatory Affairs, Quality Assurance, Teleflex

11:45 a.m. – 12:30 p.m.

Crisis Management:  How to Successfully Navigate Product Failures Defects in the Wake of Product Liability Litigation
This presentation will provide a unique perspective on what manufacturers face when there is a problem or potential problem with a product, including how to effectively manage alleged product failures in the face of litigation, what to expect, and what preemptive or proactive steps can be taken during the development and approval process as well as postmarket stages to reduce the perception of negligence.

Attendees will learn:

  • Best practices for identifying and addressing product failures
  • What information will be most effectively used in product liability litigation — How to proactively define the perception it creates
  • How to preemptively position your company as transparent and compassionate while minimizing the appearance of negligence in the face of product liability litigation
  • Lessons learned from recent high profile product defects

Salena Zellers Schmidtke, BioInjury LLC

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:15 p.m.

It Takes a Village to Effectively Manage CAPAs — How Covidien Developed Its "CAPA Board"
CAPAs that are not managed through the entire operational process — and do not include multiple departments — tend to be less robust.  Covidien employs a CAPA Board (CAB) consisting of cross-functional managers and/or senior individual contributors that meet on a regular basis to not only track CAPA progress but to review and challenge the data entered into open CAPAs.  The board decides/evaluates everything from when to open a CAPA to reviewing the implementation, effectiveness and the completion of the CAPA file prior to closing.  This is important, as the next time you open that CAPA will probably be in front of an FDA investigator.

Attendees will learn:

  • How Covidien structured the CAB and its responsibilities
  • The importance of good documentation — some obvious things will surprise you
  • Criteria for opening CAPA
  • Review points to evaluate determined root cause(s) and corrective/preventive action(s)
  • Best practices for evaluating implementation plans and proposed effectiveness checks
  • Checklist of points for closure of a CAPA

David Orton, Senior Director, Corporate Compliance, Covidien

2:15 p.m. – 3:00 p.m.

Design Control Practices for Medical Devices
Applying design controls to medical devices requires alignment with various international directives and standards.  This presentation will show the alignment of design controls with business process (new products and change control), risk management, software development lifecycle and associated safety standards.

Attendees will learn:

  • How to align design controls to new product and existing design programs
  • Best practices for integrating risk management during the design lifecycle
  • Understanding how the software development lifecycle intersects with design control
  • How quality standards assure essential requirements are met

Elizabeth Blackwood, Vice President, Supply Chain Quality Strategy, Johnson & Johnson

3:00 p.m. – 3:15 p.m.

Refreshment Break

3:15 p.m. – 5:00 p.m.

Panel Discussion: Latest on Postmarket Surveillance and 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 interested 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.

Elaine Messa, Executive Vice President, Becker & Associates

Featured Speaker:
Thomas Gross, M.D., Acting Director, Office of Surveillance and Biometrics, CDRH, FDA

Thomas Gross, M.D., Acting Director, Office of Surveillance and Biometrics, CDRH, FDA
Isaac Chang, Division Director, Office of Surveillance and Biometrics, CDRH, FDA
Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch, Division of Post Market Surveillance, Office of Surveillance and Biometrics, CDRH, FDA
Patrick Caines, Director Quality Assurance, Boston Scientific

5:00 p.m. – 6:30 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.

Keynote:  ORA Enforcement Update
Warning letters, seizures and injunctions continue to rise. The FDA issue 673 warning letters in FY 2010, nearly 200 more than that in FY 2009. Seizures have almost doubled in that same time frame, from 6 to 10. With ORA’s manpower at an all-time high with 4,400 full-time equivalent employees in 2011, 2012 could be the year of increased enforcement measures. Ms. Corrigan will discuss the enforcement trends through the years so you can be better prepared for what is to come.

Dara Corrigan, Associate Commissioner for Regulatory Affairs, ORA FDA (invited)

10:00 a.m. – 10:45 p.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, Vice President, Corporate RA, Medtronic

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 12:45 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.

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
Heather Rosecrans, Senior Regulatory Advisor, Greenleaf Health; Former Director of the 510(k) Pre-Market Notification, CDRH, FDA
Joni Joy, Deputy Director, Office of Device Evaluation, CDRH, FDA
Laurie Clarke, Partner, King & Spalding

12:45 p.m. – 1:00 p.m.

Closing Comments by Co-chairs Steven Niedelman and Elaine Messa

1:00 p.m.

Conference Adjournment