2013: FDA’s Year of Quality

“Quality is one of our highest priorities.”
Margaret Hamburg, US FDA Commissioner, 22 Feb 2013

Compliance Architects^® can help you improve your quality and compliance outcomes with innovative approaches focused on remediating the structural causes of quality and compliance risk.  Contact us now and reduce your FDA enforcement risk today!

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Resolve Product Quality Deficiencies

• Reduce non-conforming product

• Resolve manufacturing problems

• Identify actionable cause(s)

• Define appropriate CAPA scope

• Audit & work with suppliers

• Remediate problem specifications

Avoid Executive Risk

Quality and Compliance executives look to our deep subject matter expertise when wrestling with the following problems:

• Hiring freezes

• An aggressive FDA

• Budget cuts

• Product quality problems

• External suppliers

• Pressure to improve results

• Complicated documents and systems

• Falling behind on CAPA

• Poor process understanding

FDA 483 & Warning Letter Response & Remediation

Responding to FDA enforcement actions (FDA 483 observations & warning letters) requires the ability to integrate FDA quality systems and compliance expertise under an umbrella of rigorous project and program management, to ensure committments are strictly monitored and deliverables accomplished.  Compliance Architects® can provide the leadership, expertise and resources to resolve the most complicated and risky enforcement actions.

Supplier Quality Audits & Supplier Quality Management

A “perfect storm” of events has created significant compliance risk for FDA-regulated companies.   Every company MUST have a robust supplier quality and audit program in place or, their entire supply chain could be at risk!   Compliance Architects^® has developed a breakthrough supplier quality audit and quality management program.  Contact us now and reduce your supplier quality enforcement risk TODAY!

Inspection Readiness for a More Aggressive FDA

It has never been more important to be “ever-ready” for an FDA inspection.  Without expert guidance on readiness approaches, a company is at the mercy of FDA Investigators and may experience significant remediation costs, distraction from business objectives, or worse, a possible business shutdown.   Compliance Architects® can provide the leadership, resources and methodology to ensure your next inspection isn’t your last inspection.