(FDAnews: Falls Church, VA) -- Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin, which occurred in 2010 when Baxter Healthcare distributed misbranded and contaminated doses of the drug, “seems inevitable.”
All together, the number of offshore suppliers has nearly tripled in recent years. China alone has nearly 1,000 makers of drug substances and only a small percentage of inspections.
Whether you make drugs or devices, biologics, or third-party goods, when your suppliers slip up, it’s you the FDA comes after. Ideally, regulators should be covering your back with tough inspections of offshore suppliers, but realistically, the agency simply is spread too thin to do the job.
Learn how to ensure the integrity and quality of your supply chain. Put yourself at the head of the class and avoid 483s (FDA warning letters) and lawsuits by taking the lead. You can take charge of your supply chain by joining the top speakers in Washington in August to learn about the tools you need. Mark your calendar for the Third Annual Supplier Quality Management Congress, scheduled for Aug. 9–11, 2011, in Bethesda, Maryland.
The congress consists of a day and a half of intensive learning, a crash course in supply-chain management and monitoring. Here’s just a sample of what you’ll discover:
• The FDA outlook on supplier quality and compliance
• How to create comprehensive supplier quality agreements
• An assessment tool for choosing the right supplier
• How to conduct on-site supplier audits and apply best-practice risk management techniques
• Supplier metrics and their role in the quality management system (QMS) management review
• Can’t-miss audit plans and supplier quality-auditor training programs
• Special for device makers: Updates on the Global Harmonization Task Force (GHTF) and device outsourcing trends
• Special for drug and biologics manufacturers: Creating qualification management systems
Presenters include an all-star cast of industry stars, members of the bar, consultants, and invited FDA officials, including:
• Kimberly Trautman, medical device quality systems/GMP expert, Office of Compliance, CDRH, FDA
• Jan Welch, consumer safety officer, Office of Compliance, CDRH, FDA
• David Jaworski, consumer safety officer, Division of Manufacturing and Product Quality, CDER, FDA
• Larry Spears, deputy director for regulatory affairs, CDRH, FDA
• Steven Wolfgang, consumer safety officer, Division of Manufacturing and Product Quality, CDER, FDA
Conference co-chairs John Avellanet of Cerulean Associates LLC and Steven Sharf of GMP Concepts will be on hand to keep matters on track and moving forward.
Workshop A—Medical Device Supplier Qualification and Management: Practical Approaches to Cost-Effective Implementation
Regulators worldwide are looking more closely at supplier-management issues as device manufacturers extend their processes down the supply chain and acquire components across national boundaries.
Are you ready for the increased scrutiny from FDA investigators and Notified Bodies?
Workshop B—The Pre-audit Supplier Questionnaire: How to Make It Relevant and Useful
At one time or another, we have all either sent out a pre-audit questionnaire or have been on the receiving end of one with a due date of about two weeks. That’s two weeks to complete a document of more than 20 pages.
Pre-audit questionnaires should be treated like audit reports and put together with the same kind of thought and care that we complete our reports. Suppliers see 50 of these a year, and each time they think to themselves, “Another questionnaire that no one will look at.” Let's change that and make it a value-added document.
Click here to see the full conference brochure and register.