Off-the-Shelf Versus Custom-Built Quality Systems What Works, What Doesn’t and Why

Held Sept. 18, 2012

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.

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Have any of these happened at your firm lately?

  • You’ve outsourced more operations — some of them vital and critical to your product
  • Management is pushing you hard to release new products faster
  • Who’s the new guy?  You’re always dealing with new personnel
  • FDA process validation guidances have required you to make major changes to individual procedures

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:

  • Who can use an "off-the-shelf" quality system and who definitely cannot
  • 10 common mistakes firms make surrounding the “buy-versus-build” decision
  • How to build quality systems around the natural processes inherent within a company’s unique business models
  • Why teams that manage “base systems” are not the best for developing new systems
  • What an ISO 13485 Certificate really means — and how does it factor into your “buy-versus-build” decision
  • How to align and implement design controls, transfer product design to manufacturing operations and maintain a state of compliance
  • Understanding the differences between “perceived compliance” and “permanent compliance”
  • Tips for getting management buy-in regardless of the type of system you choose

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.

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  • Device industry managers
  • Quality assurance and quality control specialists

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

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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