You are responsible for the quality of your product, regardless of what areas of your operation you outsource. FDA regulations have made this very clear. The company of record for Heparin could be facing trouble after subcontracting work to a Chinese manufacturer, which subsequently lead to four deaths and hundreds of illnesses. Avoid warning letters, recalls, seizures, and potential lawsuits.

In a new Diagnostics & Imaging Week/Medical Device Daily audio conference, speaker Dennis Moore, president and CEO of AUK Technical Services, will provide insight on topics such as supplier's practices, what they do about non-conforming product, what to look for in CAPA, product release, training, customer complaint handling and more.

"Auditing Suppliers and Contractors: Be Ready for Increased FDA Scrutiny" is just $349 per listening site. Scheduled for May 1st, from 1-2:30 p.m., it includes presentation handouts and a half-hour Q&A session with the speaker. A conference CD (MP3 format) is also available. For more information or to register, call 800-688-2421 or 404-262-5474. Please mention conference code T08491.