Gaining Value From Implementing ISO 14971/Risk Management for Medical Devices. U.S. and Worldwide Expectations
> Scott Cohn
QA Compliance Team
Stryker Othopaedics

Risk Management is rapidly gaining focus as an integral part of medical device design. Learn how to incorporate an effective risk management system into your design and development programs. This presentation will cover the expectations of the FDA as well as other worldwide regulatory bodies with regard to managing patient risk, as well as the common pitfalls inherent with many risk management programs. The information presented will help companies not only meet industry expectations, but will also help them learn how to gain internal value from an effective risk management system.

About Scott Cohn:
Scott is a 15-year veteran of the medical device industry. He has worked for several large and small companies implementing and/or improving their quality management systems. He is currently a member of the QA Compliance team at Stryker Orthopaedics, the largest division of one of the world’s leading orthopaedic device companies, where he recently led a multi-disciplinary cross functional team that designed and implemented a new risk management system.

Lessons from Litigation:
Utah Medical Products, Inc. and Good Manufacturing Practices
> Larry Pilot
Partner
McKenna, Long & Adridge

Mr. Pilot will cover several lessons learned, including:

• Inspections and Administrative Follow-up
• Warning Letters and Certificates to Foreign Governments
• Suing the Food and Drug Administration
• When FDA Sues
  • The "Sign or Sue" Letter
  • Settlement Options
  • Consent Decree/Disgorgement
• Litigation
• Litigation - Federal Rules of Civil Procedures
• Trial and Opinion

Risk Management—
A complete Life Cycle Approach
> Dr. Harvey Rudolph
Global Program Manager, Medical Devices
Underwriters Laboratories, Inc.

There is no question that risk management is required in all major medical device markets.  Regulatory authorities worldwide expect manufacturers not only to manage risks during the design phase, but also to apply risk management principles throughout the product life cycle.

To accomplish this, manufacturers must utilized all of the quality data generated within their quality management system.

Using ISO 14971 and ISO 13485 as models, this presentation will examine how to integrate risk management principles into a quality management system so that the complete life cycle approach to risk management can be realized. Common mistakes made as well as hurdles to overcome in accomplishing this will be discussed.

China Regulatory Compliance for Medical Device Companies - Challenges and Opportunities-
>Chang-HONG WHITNEY
President
Whitney Consulting Limited

With the growth of the Chinese medical device market, Chinese government is tightening up its controls and regulations on the medical device products. State Food and Drug Administration (SFDA) is the top government agency that formulates and implements policies and regulations for this industry. Since 1998, SFDA has been gradually improving its regulations. The policy issued in Year 2000 formalized product registration, safety testing and management of medical device manufacturers. This seminar is aimed to explore the SFDA functions and regulations that pertain to US medical device manufacturers and their products on the Chinese market. The speaker will share her extensive experience and expertise in managing China regulatory compliance, registration process, challenges and opportunities. Topics will include product registration, type testing, labeling, industry standards, manufacturing compliance, vigilance, and other related subjects that affect medical products in China.

About Chang-Hong Whitney:
Ms. Whitney has been in the medical device industry for more than 15 years and doing business in China for more than a decade. She established and managed her company in China since 1994 and has been consulting for multinational companies in business development, strategy and market research. She is an expert on China regulatory affairs and has written articles on this subjects and frequently speaking to the medical communities. She is also an adviser and consultant to the investment community on investments to the Chinese medical industry. Ms. Whitney holds MBA from Babson College (Wellesley, MA) and undergraduate degrees in Electronic Engineering and International Business from Chinese universities.

Design Inputs and Design Outputs
>Harvey Weintraub
Manager Design Control
System Development Core R&D
Abbott Laboratories

Mr. Weintraub will cover:

• Who the customer is
• Definition of Design Inputs and what else to include
• Definition of Design Outputs and what else to include

Strategies for Effective Medical Device Reporting
>DEbbie Yoder
Nurse Consultant, Reporting Systems Monitoring Branch,
Center for Devices and Radiological Health
U.S. Food and Drug Administration

>Mary Brady
Deputy Division Director, Division of Surveillance Systems, Office of Surveillance and Biometrics, Center for Devices and Radiological Health
U.S. Food and Drug Administration

This presentation will cover the following key points:

• Explanation of MDR reporting requirements
• What is and isn't reportable and why?
• Key terminology
• Examples of effective MDR activities
• How to avoid pitfalls in decision-making criteria for what to report
• The risks of failing to report
• When and how FDA communicates with foreign governments

Medical Device Reporting: Problem Solving Exercise in a Team Environment
>Mike Crader
Vice President Regulatory Affairs
Hill-Rom

Utilizing problem-solving exercises in a team environment, attendees will learn to apply their technical expertise in the application of Medical Device Reporting principles to real life examples. Attendees will be challenged to understand issues that commonly face industry such as:

• Determining user error, misuse, or abuse
• Timely reporting and when the clock starts ticking
• Serious injury and what is meant by medical or surgical intervention
• How many reports to file for multiple incidents, multiple products used in an incident, or multiple products implicated in an incident

Everything You Need to Know About FDA Enforcement Actions
>MaRK BROWN
Partner
King & Spalding LLP

This presentation will cover the following key points:

• Types of FDA enforcement actions
• How to avoid enforcement actions
• What to do if you are the target of enforcement actions
• How to recover from FDA enforcement actions

About Mark Brown:
Mark Brown is a partner in the firm’s FDA/Healthcare Practice.  He joined the firm after serving five years with the U.S. Food and Drug Administration (FDA) Office of the Chief Counsel.  Mr. Brown represents clients on various FDA regulatory compliance issues, including manufacturing practices, product failure investigations, factory inspections, clinical trials, adverse event reporting, recalls, product labeling, advertising and promotion issues and criminal investigations.  He also regularly advises clients on developing strategies for obtaining FDA approval and clearance for medical products.

Mr. Brown has extensive experience in FDA compliance and product approval issues that arise in products liability litigation involving medical devices and in advertising disputes between competing companies pursuant to the Lanham Act.

Ensuring Success in Application Submission and Approval -- Major Considerations in GCP, QSR and GLP
>Charma A. Konnor, R.Ph., RAC
Senior Manager/Consultant, Devices and Drugs
Phoenix Regulatory Associates, Ltd.

Key points for success in application submission and approval. How to avoid pitfalls and systemic mistakes that can lead to failure such as:

• no application approval
• delay in approval
• application integrity problems