IMPROVE FDA Enforcement Responses & Action Plans

Uh oh – so you received an FDA-483 or Warning Letter.   Don’t despair – you can still resolve your FDA enforcement issues without significant risk to your company.   Be clear though:  responding to FDA enforcement actions is one... Read more

ELEVATE Quality & Compliance Department Performance

Is your Quality and Compliance Department effective?  How do you know?   If FDA showed up tomorrow, would a positive inspection outcome be certain?   Have you developed a Quality Strategic Plan?    Are your issues and gaps collected,... Read more

EXPAND Control of Supplier Quality Activities

A Very Public Supply Chain Risk A “perfect storm” of events has created significant quality and compliance risk for FDA-regulated companies.  High-profile failure events at suppliers and contract manufacturers has created a hyper-awareness by FDA of a company’s... Read more

SUSTAIN Quality & Compliance Improvements

Sustainability What is “Sustainability”?  In the context of business initiatives and investment, and more particularly in the context of quality and compliance remediation activities, sustainability can be defined as the process of maintaining that which you’ve created, repaired,... Read more

REMEDIATE Deficient Quality & Compliance Documentation

[su_spacer size="20"]FDA-regulated companies communicate with FDA Investigators through their documents. Poorly written, confusing or disconnected documents can result in an Investigator not understanding your quality system and a poor inspection outcome. Improving your company’s writing skills and documents will... Read more

REDUCE FDA Inspection Risk

It goes without saying that FDA Inspections are critically important. Business impacts from a single inspection can range from millions to hundreds of millions of dollars in some cases.  What is troubling is that many companies go from... Read more