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Wednesday, September 14, 2011
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Implantable Device Design |
2:00 – 4:00 |
Part IV: Working with Suppliers |
Relationship of Risk Management and Contracts: Steven Niedelman, Lead Quality Systems and Compliance Consulting, King & Spalding
Outsourcing, throughout the medical device industry has grown exponentially over the past decade from both domestic as well as international sources. The medical device industry assured FDA they would be responsible for assuring the quality of the components, sub-assemblies, parts and even finished devices they receive from suppliers. Lowest price and timely delivery are no longer the only acceptable attributes manufacturers must consider and evaluate to assure the quality of the products and services they outsource. It is increasingly critical that manufacturers of medical devices establish an effective, risk based supplier quality program - an element of which includes Supplier Quality Agreements that clearly define expectations and requirements to provide them the assurance and trust in the products and services they are outsourcing. Some consider the Supplier Quality Agreement between the manufacturer and supplier to be the most critical element of such a program that will assure quality while reducing your firm's liability and risk. During this session you will learn:
• The importance of an effective risk based Supplier Quality program and the elements for success
What to Expect from Supplier Agreements
Working with Biomaterials Suppliers: Shanger Wang, Senior Staff Scientist, DSM
Selecting and using materials for innovative medical devices is a challenge. Finding the right supplier and partner with the experience and track record of not only providing candidate materials, but also with the capability and experience of fine-tuning material specifications and performance, providing data and design support, samples, process assistance and support of regulatory processes (Quality Control, Material Master Files) can prove just as challenging. Through several case-examples, it will be discussed:
• How a materials supplier can help in the design of products and technologies
From Sourcing to Service: A Contract Manufacturer's Perspective: Tom Black, Vice President, Sales and Marketing, OEM and International Divisions, B. Braun Medical Inc. More than products move among OEMs, raw material suppliers, outsourcing partners and patients. Today, the flow of information is more critical than ever. From the initial articulation of end-use requirements to product specifications, material data, validation and test results, outsourcing partners are taking an essential role as providers, creators and stewards of information that is used for regulatory and quality control purposes. Mr. Black will examine how information moves throughout the supply chain and how outsourcing partners interact with other parties to ensure that products meet market needs within cost containment measures. Supplier Controls Within a Multinational Manufacturing Company |
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Admission to the Conference is complimentary for employees of qualifying implantable device manufacturers.
For all others, a registration fee will apply. Your colleagues can register online at MEDeviceForum.com.
ABOUT THE SPEAKERS
Steven Niedelman, Lead Quality Systems and Compliance Consulting, King & Spalding
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.
He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting.
Mr. Niedelman consults with manufacturers, importers, new product developers, as well as with firms involved in or facing enforcement actions. He helps firms develop corrective action plans so their business needs are properly balanced with regulatory requirements in order to achieve compliance without compromising objectives. He provides training and guidance to industry professionals on all FDA requirements, including quality systems requirements, inspection preparedness, post-market obligations and to executives about their management responsibilities as well as FDA's expectations.
Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA's regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA's nearly 3,400 field staff responsible for investigative and laboratory operations.
While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical "cGMP for the 21st Century" initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the Director and Deputy Director of FDA's Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities to ensure fair implementation by FDA's five product centers. During his tenure, Mr. Niedelman presided as the Chairman of FDA's Compliance Policy Council. He currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute and as a member of the Editorial Review Board for FDA News GMP publications directed at the pharmaceutical and medical device industries. Mr. Niedelman has also served as Vice President of the FDA Alumnae Association.
Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health (CDRH) in a number of management positions. During those nearly 24 years at CDRH he was responsible for implementing many of the newly created statutory requirements and drafting and shaping many of the regulations and policies affecting the sale, distribution and promotion of medical devices. He began his FDA career in 1972 as an Investigator in FDA's New York District Office.
Shanger Wang, Senior Staff Scientist, DSM
Shanger Wang Senior Staff Scientist Product & Formulation Development, DSM Biomedical. Shanger Wang is a Senior Staff Scientist for Product & Formulation Development at DSM Biomedical. In this position, he works on a series of R&D/Technology activities and is responsible for leading the execution of product formulation development projects in support of overall business development. Shanger transforms customer specifications into work proposals and develops new applications in cooperation with customers, resulting in specified and approved products. Shanger has over 16 years of experience in R&D in both corporate and academic settings. He has held chemist and scientist positions at Indium Co. of America, The Polymer Technology Group, and DSM Biomedical as well as university research positions at Changchun Institute of Applied Chemistry, Chinese Academy of Sciences, Université de Montréal, and the Lawrence Berkeley National Lab. Shanger's areas of expertise include chemical structure-properties relationships and the development of novel products and technologies focused on biomedical applications. He is experienced in working with next generation silicone hydrogel materials, bioresorbable polymers, matrix systems for drug delivery, and polymers with inherent antimicrobial and anti-fouling surfaces for short- and long-term medical implants.
Shanger has a broad background of multi-disciplinary industrial research experience including idea generation, feasibility experimentation and development & product commercialization in compliance with ISO13485 design control and other applicable quality system regulations. Shanger earned a Ph.D. in polymer chemistry from the Changchun Institute of Applied Chemistry at the Chinese Academy of Sciences, as well as a Bachelor's of Science degree in organic chemistry from Ningbo University in Ningbo, China. Furthermore, Shanger holds 14 (co)authored patents and has over 30 publications in peer-reviewed journals.
Tom Black, Vice President, Sales and Marketing, OEM and International Divisions, B. Braun Medical Inc.
Tom Black, Vice President of Sales and Marketing for the OEM and International Divisions of B. Braun Medical Inc., is responsible for overseeing the sales and promotion of the divisions'' products and services. Black has over two decades of experience in the OEM industry with B. Braun. He is frequently requested as a speaker about trends and management issues at medical device conferences. His expert commentary is sought regularly by industry publications and he sits on the advisory board for one prominent magazine.
Black works closely with customers and helps them meet their strategic challenges through contract manufacturing and project management solutions. He holds a B.S. in Finance with a minor in Marketing from the University of South Carolina and a Medical Marketing certificate from UCLA. He served for six years with the U.S. Air Force in Tactical Air Command.
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