Contract Manufacturing Risk Assessment Apply the Right Degree of Oversight to Your Riskiest Suppliers

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In the wake of the Heparin fiasco, the FDA and Justice Department are pushing strict liability cases against drug- and device-makers. Learn how to spot your “bad apples.” Read on ...

Ever since an insufficiently monitored overseas supplier triggered the Heparin disaster, FDA has been shining a laser light on the supply chain. Chances are 99% of your suppliers are dependable ... but that other 1% could get you in more trouble than you could handle.

How do you assess supplier risk? Could your systems use a tune-up?

Log on for a web-based learning session that supplies the answers you need. We’ve invited a shining star of quality management, Jackie Torfin of Arizant Healthcare, to share her secrets.

Using two detailed case studies and a 7-factor risk assessment scale adaptable to any drug, device, biologic or diagnostics manufacturing operation, your presenter walks you through the steps of assessing the likelihood of a supplier-caused mishap and its impact on your products or services.

You’ll learn how to assign a numerical score that ranks each supplier, every risk, to help you zero in on the weak links in your supply chain. Then, you’ll discover proven strategies and techniques to exercise oversight and lessen supplier-caused risk. Make sure you’re taking notes as your instructor covers these key points and more:

  • Rapid review of FDA and ICH regulations governing contract facilities — hot-spots that regulators are targeting
  • Best practices for conducting CMO risk assessments — how soon is too soon to start the process
  • How to ensure SOPs are in place that clearly determine the level of monitoring and control required for each supplier
  • Identifying major and critical high-risk CMOs to determine when risk mitigation plans are necessary
  • Understanding characteristics of risks — high, moderate, low
  • The 7-risk assessment scale — regulatory inspection history, company audit history, recalls, production history, batch record review, change control, quality agreement
  • Plotting and calculating risk scores to develop risk mitigation strategies

Get set for 90 minutes of nonstop learning. And don’t forget your questions! This session is web-based and totally interactive, so you can email questions and get answers by the time you and your staff log off.

That’s right — as many staff may participate from one location as you like. Since there’s no extra charge — even if hundreds participate — it makes sense to sign up every executive involved in quality, manufacturing, distribution and engineering, not to mention regulatory and legal staffers.

  • Quality assurance/quality control executives and staff
  • Operations
  • Manufacturing
  • Materials management
  • Purchasing
  • Packaging and labeling
  • Plant engineering
  • Regulatory affairs
  • Legal counsel

Some companies deal with thousands of suppliers in dozens of locations worldwide. With the FDA and other regulators getting ever tougher on manufacturer liability for supplier-caused problem, the need to learn risk management principles that deal with the challenge — plus best practices when you discover suppliers that pose major risks — has never been more urgent. Can you afford not to sign up?

Jackie Torfin is Director of Quality at Arizant Healthcare. Over a 20-year career in in-vitro diagnostics/medical devices, she has worked in quality control, quality assurance, project management, and management of CMO manufacturing organizations. She has managed more than 15 pharmaceutical partnerships and supervised the management of more than 20 different CMOs.

Register now!

Date: Nov. 2–20, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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