Conference

Wednesday, October 22, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)

Session 200 - How to Quickly Discover and Respond to a Serious Product Quality Problem

Chair: Michael Barile, Barile & Associates Overview; The Big Picture: Michael Barile Product Performance Monitoring, in the Factory and in the Field: How Do I Do It? Jonathan W. Demarest, Respironics, Inc. OK, We Have a Problem, Now What? How to Gauge the Significance of a Quality Problem. Andrew Snow, Vice President and General Manager, HEI Inc. To Recall or Not to Recall, That is the Question. And How do You Manage a Recall, Anyway? Andrew Snow, Vice President and General Manager, HEI Inc. Dealing with the Authorities: What Do I Tell FDA, the European Competent Authorities, the Japanese MOH, etc., When do I Tell Them and How do I Get Ready for FDA's Inevitable Visit? Michael Barile Crisis Management: Dealing with the Press and Public: Michael Barile

Overview; The Big Picture

Abstract

An introduction to the trials and tribulations associated with a serious medical device quality problem, illustrated with actual examples. The regulatory and product liability consequences are probed and the stage is set for the balance of the day’s presentations.

About the Instructor

Michael Barile, Managing Partner, Barile & Associates
Michael Patrick Barile has over twenty five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in turnaround situations. He is the founder and Managing Partner of the consulting firm Barile & Associates.

Comprised of a group of senior quality, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the medical device, pharmaceutical, human tissue and biotechnology industries. This support includes complete quality system development; software, process and design validation services; complete design control services; risk management services; 483, Warning Letter and Consent Decree resolution; auditing; crises management; corrective action plan generation and execution; regulatory submissions; training, staffing, and organizational development.

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Product Performance Monitoring, in the Factory and in the Field: How Do I Do It?

Abstract

The key to quickly discovering a previously unidentified quality problem is effective trending and statistical treatment of quality data. This session will examine several approaches.

About the Instructor

Jonathan W. Demarest, Director, Quality Systems, Respironics, Inc.
Jonathan has been working with medical device, pharmaceutical and biotech companies for the last 25 years providing leadership in the acquisition and evaluation of performance data in the design process, in production and for post marketing. He has contributed to such companies as Becton Dickinson, Baxter, Boston Scientific and Smith Medical International.

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OK, We Have a Problem, Now What? How to Gauge the Significance of a Quality Problem

Abstract

Once a quality problem has been identified, how do you gauge the significance of the problem and determine the appropriate response? This session will examine a risk-based approach to determining the extent of the problem and its potential patient impact in order to develop appropriate containment and corrective action plans.

About the Instructor

Andrew Snow, Vice President and General Manager, HEI Inc.
Andrew Snow is a Quality Assurance professional with over 25 years of progressive quality engineering and management experience. He holds a BS in Biology from Fort Lewis College, a Masters in Engineering from Northwestern, and a graduate certificate in Systems Engineering from University of Arizona. He currently is the Vice President and General Manager of Quality and Regulatory for HEI Inc. Prior to this he was a consultant helping numerous companies including Alcon Laboratories and Abbott Laboratories. He has extensive hands on quality assurance, design and manufacturing experience in Medical Devices. He has expertise and proven results in Quality Systems implementation, Process Validation, Design Control, Concurrent Engineering methods and Risk Analysis. Andy is an ASQ certified Quality Engineer, and a trained ISO 9000 Lead Assessor. He was an instructor in Statistics, and Quality and Productivity Management at the University of Phoenix. He has published articles on Risk Management, Design Control and Process Validation.

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To Recall or Not to Recall, That is the Question. And How do You Manage a Recall, Anyway?

Abstract

The decision to recall a medical device is never a simple one. This session will examine the factors to consider in making this determination and give guidance for the conduct of a recall should you choose this action.

About the Instructor

Andrew Snow, Vice President and General Manager, HEI Inc.
Andrew Snow is a Quality Assurance professional with over 25 years of progressive quality engineering and management experience. He holds a BS in Biology from Fort Lewis College, a Masters in Engineering from Northwestern, and a graduate certificate in Systems Engineering from University of Arizona. He currently is the Vice President and General Manager of Quality and Regulatory for HEI Inc. Prior to this he was a consultant helping numerous companies including Alcon Laboratories and Abbott Laboratories. He has extensive hands on quality assurance, design and manufacturing experience in Medical Devices. He has expertise and proven results in Quality Systems implementation, Process Validation, Design Control, Concurrent Engineering methods and Risk Analysis. Andy is an ASQ certified Quality Engineer, and a trained ISO 9000 Lead Assessor. He was an instructor in Statistics, and Quality and Productivity Management at the University of Phoenix. He has published articles on Risk Management, Design Control and Process Validation.

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Dealing with the Authorities: What Do I Tell FDA, the European Competent Authorities, the Japanese MOH, etc., When do I Tell Them and How do I Get Ready for FDA's Inevitable Visit? 

Abstract

When and what you tell the FDA and other regulatory authorities concerning a serious quality problem can either increase or decrease your firm’s regulatory risk dramatically. This session will examine strategies to increase the likelihood of success.

About the Instructor

Michael Barile, Managing Partner, Barile & Associates
Michael Patrick Barile has over twenty five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in turnaround situations. He is the founder and Managing Partner of the consulting firm Barile & Associates.

Comprised of a group of senior quality, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the medical device, pharmaceutical, human tissue and biotechnology industries. This support includes complete quality system development; software, process and design validation services; complete design control services; risk management services; 483, Warning Letter and Consent Decree resolution; auditing; crises management; corrective action plan generation and execution; regulatory submissions; training, staffing, and organizational development.

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Crisis Management: Dealing with the Press and Public

Abstract

The crises associated with a serious product quality problem can spiral into a public relations nightmare. Effectively dealing with the press and public is essential to minimizing the long term consequences of the crises on your business. This presentation will examine critical success factors that companies have used in times of crisis.

About the Instructor

Michael Barile, Managing Partner, Barile & Associates
Michael Patrick Barile has over twenty five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in turnaround situations. He is the founder and Managing Partner of the consulting firm Barile & Associates.

Comprised of a group of senior quality, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the medical device, pharmaceutical, human tissue and biotechnology industries. This support includes complete quality system development; software, process and design validation services; complete design control services; risk management services; 483, Warning Letter and Consent Decree resolution; auditing; crises management; corrective action plan generation and execution; regulatory submissions; training, staffing, and organizational development.