Supplier Controls Regulations and Best Practices
Hotel TBA Washington, DC October 5, 2009
Monday, October 5th 8:00 – 8:30 8:30 REGISTRATION AND CONTINENTAL BREAKFAST Welcome Thomas Maeder, Executive Director, MTLI, AdvaMed Steve Niedelman, Senior Consultant, Crowell & Moring, Conference Moderator Outsourcing and Oversight: Who, How, Why, When, and Whether? Steve Niedelman, Senior Consultant, Crowell & Moring • Why companies outsource goods and services • Business considerations in outsourcing • Domestic and overseas outsourcing of medical product manufacturing, finished goods, and services • Risks and benefits Supplier Controls – the FDA Regulations Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH • What is unique about medical device manufacturing • The Quality System Regulations and Supplier Controls • Common mistakes and misperceptions • The enforcement history o Recent warning letters related to supplier controls o Recent recalls related to supplier control issues • What FDA looks for and expects • Current and future enforcement trends BREAK A Risk-Based Approach to Supplier Controls
8:35 – 9:00
9:00 – 10:30
10:30 – 10:45 10:45 – 11:30
Frank A. Gomez, CRQS Program Manager, Quality Center of Excellence, Abbott Laboratories • Creating and implementing a supplier control plan commensurate with the identified level of risk • Challenges associated with using sole suppliers 11:30 – 12:15 Developing a Robust System in a Complex Supplier Environment James Twitchell, Corporate Director, Alliance Quality Management, Boston Scientific • Developing a robust supplier quality system • How to look for suppliers and what to look for • Recognizing red flags • Strategic considerations in overseas outsourcing • Maintaining uniform supplier controls across diverse sites and nations • Coordinating accepted vendor lists LUNCH The GHTF Document on Supplier Controls Gunter Frey, Vice-Chair, GHTF Study Group 3(invited) • Current status of the Guidance on the control of products and services obtained from suppliers Building Internal Support for Supplier Controls Bill Boumeester, Director, Supply Chain Quality & Materials Engineering, Medtronic Neuromodulation • Giving supplier controls the attention they deserve • Recognizing and communicating potential issues or problems • Management responsibility and supplier controls BREAK Heparin – The Challenges of Traceability Patricia Shrader, VP, Corporate Regulatory Affairs, BD • Case study of a difficult case of tracing a supply trail The Supplier Perspective: Critical Single-Source Components Susan H. Campbell, Senior Vice President Orthopedics, Greatbatch • Best Practices for Supplying Critical Implantable Components o Quality Systems o Prevention – Creating a FMEA Culture o Testing & Data Analysis o Disaster Recovery Planning o Supply Base Management • Optimizing the Manufacturer – Supplier Relationship o Advanced Quality Planning o Corrective Action Systems
12:15 – 1:15 1:15 – 2:00
2:00 – 2:45
2:45 – 3:00 3:00 – 3:45
3:45 – 4:30
o 4:30 – 5:00 5:00
Change Management
Wrap-Up Discussion ADJOURNMENT
Important Notice The information provided in this course represents the personal opinions of the instructors and does not necessarily represent the opinions of AdvaMed staff. Companies relying on the
information do so at their own risk and assume the risk of any subsequent liability that results from relying on the information. The information does not constitute legal advice.