The FDA won’t tell you what type of quality systems — off-the-shelf or custom built — you should have. But what you decide plays a key role in whether you remain in their good graces.
Have any of these happened at your firm lately?
These are just a few of the things that wreak havoc on your quality systems. All these scenarios create disconnects and disintegration of systems that can create significant quality, compliance and operational failures.
The key to success is picking the best systems for the way your company operates. For some firms, it’s off-the-shelf systems, for others it’s custom built. And rarely does a hybrid system work. But choosing between the two is a daunting decision.
Brian Dense, president of CiNQ Systems and a 20 year veteran of the device industry presents a 90-minute audio CD/Transcript that will teach you how to get the right quality system for your business operation.
You will learn:
In just 90 minutes, get the total picture you need to ensure your quality systems are right for your business and keep you in compliance.
Brian Dense, President, CiNQ Systems, has more than 20 years of experience working in the quality area of the medical device industry, including experience from leading global companies such as Medtronic, Synthes, C.R. Bard and Genzyme. Brian also has experience working in start-up environments, with both Novoste and NovaLign. He recently founded CiNQ Systems, providing quality system and due diligence consulting services to the medical device and pharmaceutical industries. He has extensive experience in managing quality engineering personnel in the supplier quality function at Medtronic Spinal and Biologics and performed audits on suppliers in the United States and Europe. Brian is an ASQ Certified Biomedical Auditor and has received Six Sigma Green Belt training. He believes in building quality systems around the natural processes inherent within the unique business models of each client.
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