Description:Complaint handling is one of the core aspects of medical device business, as improper or inadequate complaint handling can result in regulatory action from the FDA. This is because the FDA has very clearly spelt out, crystal clear rules on complaint handling, which many device manufacturers ignore at their own peril. The result can be costly recalls or warning letters.To add insult to the injury, the FDA announces these recalls and...more
Description:A 510 (K) premarket notification is the most common route to the market for a medical device, including in-vitro diagnostics (IVDs). It is therefore very important that a firms 510 (K) should be to the regulatory standards and be able to achieve quality submission. Firms that accomplish this will be able to save costs running into millions of dollars, since their review process will be much faster.This webinar will give participants...more
Description:This webinar is about regulations found in FDA QSR manual and how they need to be implemented. FDA's Quality system Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. These requirements cover three acceptance areas: oreceivingoin processofinalThese are discussed in this webinar. Another unique aspect of the QSR is that it has specific requirements for procedures and minimum requirements for record keeping. This webinar takes a look at the regulations and discusses the FDAs intent as provided in the preamble to the regulations. It explains the guidance offered in theFDAs QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms. In addition, the FDA has recommended, manufacturersobtaina copy of the Warning Letters to help them come into full compliance. This session will discuss how to go about this. It will also examine the rationale on which FDA issues Warning Letters. This session will offer advice on how to avoid common pitfalls that could invite Warning...more
Description:Most medical products, comprising biologics, devices, drugs and diagnostics are manufactured under strictly controlled conditions in cleanrooms. To keep contaminants out of products, cleanrooms are designed, built, validated and operated to exact specifications.However, despite the best care, such facilities can overlook the primary...more
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