Bio/Pharma ~Medical Devices ~ Consumer Goods ~ Food
GALANTE COMPLIANCE SERVICES, LLC
Regulatory Compliance & Quality Consulting Services for Regulated Industries
Product recalls are costly. They may cause personal injury, property damage and harm to the reputation of the company and its products. If not handled properly, problems with regulatory authorities and lawsuits can ensue … and for long periods of time. Doesn’t it make sense to avoid such costs? Of course it does, and yet so many companies do not invest the time and resources in preventive measures. Why? Because they are too busy with the day-to-day operations and running with minimal resources due to cost cutting initiatives to invest time and effort into a “mock recall exercise” for something that may never happen. Well, consider the upward trend of product recall events. It’s not a matter of if it will happen; it is a matter of when. The U.S. government is taking action to ensure preventive-focused tools and a regulatory framework are in place to help make substantial improvements in our approach to consumer safety. On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) that specifically requires food producers to have a recall plan as part of their preventive controls. The precedent has been set. Recall plans will soon be required for other industries too.
· Recall Plans
· Metrics and Dashboard Design
· Policy & Procedures Development
· Business Impact, Threat & Risk Analyses
· Crisis Management / Business Continuity Planning
· Tabletop Exercises
· Six Sigma Process Excellence / Process Mapping
We are a team of experts who provide realistic and practical solutions that are sustainable over time to assure quality, integrity and compliance to the satisfaction of regulatory authorities. We are located in northern New Jersey and work across the United States and abroad.
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