Simplifying Global Compliance
Reduce Supply Chain Risks How the FDA Expects You to Manage Outsourced Suppliers
Held April 16, 2009
Whether your outsourcing vendor is around the block or around the world, you’re responsible for the integrity, quality and conduct of the supplier.
You engage them, you’re liable for them. No excuses …
And now, there’s a whole different set of rules for you to follow, and more are coming. For example:
- In January, U.S. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) introduced a globalization bill mandating that the FDA inspect drug and device plants in the U.S. and abroad every two years
- In March 2008, Rep. Dingell introduced H.R. 3610, which not only requires more FDA inspections of overseas plants (which necessitates an increase in staff), but also requires pharmaceutical labels to indicate where the drugs were manufactured
- The FDA has opened offices in India and China and plans to set up more in the Middle East and Central and South America
Let former top FDA investigator Martin Browning bring you up to date in this 90-minute audio CD/Transcript as he explains how the FDA expects you to manage and monitor outsourced activities in your supply chain in 2009. He’ll examine best practices for making outsourcing decisions and what you need to do to keep the FDA informed. Plus, you’ll find out how to navigate all the agency’s rules and regulations — and much more.
- The good, the bad and the ugly of outsourced operations
- How to select outsourcing partner(s) who will adhere to your compliance standards and uphold your reputation
- When and how the FDA must be notified about your suppliers
- Top five most common pitfalls in outsourcing and how to avoid them
- Which activities best lend themselves to outsourcing — and which don’t
- FDA requirements you must address in all contracts and service level agreements to protect yourself
- How to develop and maintain a strong supplier management process
- What to do when faced with off-spec products, recalls or complaints
- The outlook for increased FDA regulatory scrutiny of suppliers in light of the heparin debacle
- Seven economic and enforcement dangers of not managing your suppliers closely
Order now and discover how to manage your outsourced suppliers in 2009 and stay FDA compliant.
This audio CD/Transcript is a must for contract manufacturing companies, API and component suppliers, as well as professionals in the drug, device, biologic and diagnostics industries, including:
- Laboratory quality control
- Legal counsel
- Materials management
- Packaging and labeling
- Plant engineering
- Regulatory affairs
is the founder and president of EduQuest. He spent 22 years with the FDA as a local, national and international expert investigator, then served as special assistant to the associate commissioner for regulatory affairs. He also served as the vice chair of the agency’s Electronic Records and Signatures Working Group, which drafted the 21 CFR Part 11 regulations. Martin served as the chair of the U.S. government’s ISO 9000 committee; on the Global Harmonization Task Force; and on the committee that developed the good manufacturing practice regulations for medical devices, otherwise known as the Quality System Regulation (QSR). He is the program chairman of the week-long Compliance Boot Camp
presented by EduQuest in cooperation with FDAnews
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