Successful Outsourcing of Product Development and Validation

There are good reasons to consider outsourcing, and there are bad reasons!  Similarly, there are certain activities that are beneficial to your company to outsource, and some that are not such good ideas.

This presentation will examine:

•     Why you should and shouldn’t outsource

•     What you should and shouldn’t outsource

•     How to choose an outsourcing partner for a successful relationship

•     Engineering the right agreement or contract for success

•     Staying in regulatory compliance when you outsource

•     Managing the relationship to keep it on-track

•     Planning Design Transfer of successful products

David A. Vogel, Ph.D., President, Intertech Engineering Associates, Inc.

Dr. David Vogel is the founder and president of Intertech Engineering Associates, Inc., of Westwood, Massachusetts.  Founded in 1982, Intertech has served clients in the medical device industry by providing electronics hardware and software development and validation services.   Additionally, Dave and his Intertech engineering team have developed engineering processes for Intertech that facilitate product design compliance with FDA Quality System Regulations (QSR) and consult with clients in improving and streamlining their processes. 

Dave was selected to participate with a joint AAMI/FDA workgroup to develop a standard for Critical Device Software Validation which was subsequently included in the IEC 62304 Software Lifecycle Standard.   He was also a participant on the joint AAMI/FDA workgroup to develop a Technical Information Report (TIR32:2004) for Medical Device Software Risk Management.  Most recently his work with the AAMI/FDA workgroup concluded in the development of TIR36:2007 on the Validation of Software for Regulated Processes. 

Preventive Action, Correction, and Corrective Action: From Requirements to Effective Processes

The presentation explains the requirements in ISO 9001, ISO 13485, and the FDA QSR, cutting through the confusion often associated with Preventive Action, Correction, and Corrective Action.  Building on this clear understanding, the presentation explains how to design and implement effective systems and develops metrics for effectiveness and efficiency. We also explore the relationship that CAPA system has to other systems in the regulations including corrections and removals and management review.

Dan O’Leary, CQE, CRE, CSSBB, President, Ombu Enterprises, LLC

Dan O’Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by  APICS in Resource Management.
 

Complaint Processing within a CAPA System

Complaint Handling, CAPA, and Risk Management need to be seamlessly integrated processes.  This presentation describes requirements and best practices for these processes.  Illustrative cases will be presented and discussed.

Chas Burr, Graduate Program Director – Health Product Regulation, Regis College

Chas Burr splits his time between academia and industry, as Graduate Program Director for the Regis College Masters Degree in Health Product Regulation, and as President and Principal Consultant of Chas Burr Q/R Services, Inc.  Chas was Vice President of Quality and Regulatory Affairs for Breakaway Imaging, LLC and Director of Quality and Regulatory Affairs for Argose, Inc, two medical device start ups.  He held many quality and regulatory management positions in the Medical Products Group of Hewlett-Packard and Agilent Technologies.  Chas Burr has been active in standards development and medical device trade associations.  Personally or through his company, he is a member of AAMI, ASQ, MassMEDIC, RAPS, and the Medical Imaging Technology Alliance (NEMA).  Chas brings the experience of a career in medical technology and over 22 years in medical device regulatory affairs and quality system management. 

Changes to the Medical Device Directive

This presentation will discuss the changes to the newly revised MDD, as well as the interpretation and implementation of the changes by the Notified Bodies.  Specifically, what the changes are and how they will be implemented by the manufacturers and the Notified Bodies and when they will become effective.

Jennifer Bromm, RAC, Medical Products Manager, TUV-USA, Inc.

Jennifer Bromm is the Medical Products Manager for TUV-USA, Inc. a member of the TUV NORD Group, which is a European Notified Body for Medical Devices.  Jennifer has a BS in Microbiology and an MS in Manufacturing Management.  She worked in the quality and regulatory areas of medical device manufacturing for over 25 years before joining TUV-USA.  Jennifer's experience includes small and large device manufacturers with an emphasis on cardiology devices.  She works with TUV-USA as a lead auditor and product reviewer for sterile disposable and implantable medical devices, in addition to serving as the manager of the medical business unit in the US.

Managing the Supply Chain - GHTF Supplier Management

All elements of control from design through disposal are required to be put in place to ensure continued safety and performance throughout total life cycle.  Different parties are involved, but the objective is positive control of product and services-processes suppliers.  The specifics of how the draft GHTF document addresses some of these issues will be discussed.

Susan C. Reilly. Principal, Reilly & Associates, LLC

Susan Reilly has over 20 years of quality system, quality engineering, and regulatory compliance experience in the medical device area.  Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.  Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc.  She was also a Quality Engineer at Burron Medical Inc.

Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force.  She is a member of the Advisory Committee for the ASQ Certified Quality Auditor – Biomedical Certification and a past member of the AdvaMed (formerly HIMA) QA Committee. 

Ms. Reilly is a contributing author to “The Biomedical Quality Auditor Handbook” (ASQ) and the original technical editor for "The Quality System Compendium - GMP Requirements and Industry Practice" (AAMI).  Ms. Reilly was also a member of the committee that developed the AdvaMed “Points to Consider When Preparing for a QSIT Inspection” documents.