Recidivist warning letters are unique. They’re so unique, in fact, that many companies don’t realize they can be issued even...
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Case Studies
Staffing Support Leads to Successful Resolution of Consent Decree
A leading cardiovascular company (henceforth known as the Client) initially approached QualityHub after receiving multiple warning letters. QualityHub immediately performed...
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Resolving Consent Decree Issues with QualityHub as Third-Party Experts
Consent decrees, when left unaddressed, can quickly escalate into additional costly penalties such as removal of product from market, injunction,...
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Rigorous Corporate Audits Saves Client Future Headaches
Top executives can delegate responsibilities to a quality system like auditing, but they cannot escape the accountability that falls back...
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CAPA System Overhaul
When QualityHub is brought on to do CAPA system revisions, it is often more reactive than proactive. However, one particular...
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Resolving a Corporate Warning Letter and Laying New Groundwork
A global leader in cardiovascular health (henceforth known as the Client) reached out to QualityHub with a critical and unique...
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Overcoming Staffing Issues to Gain Compliance – Case Study
A leader in In-Vitro Diagnostics (henceforth referred to as the Client) reached out to QualityHub to overcome resource constraints and...
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QReview Case Studies
QReview is QualityHub's latest offering to clients, an On-Demand remote document review and consulting service, that gives you the expertise...
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Auditing Case Studies
At QualityHub, we have experience in FDA auditing for several types of companies and situations. Here are three examples of...
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Case Studies: Regulatory Strategy
At QualityHub, we have experience in regulatory strategies for several types of companies and situations. Here are two examples of...
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Case Studies: FDA Compliance Remediation
At QualityHub, we have experience in FDA compliance remediation for several types of companies and situations. Here are two examples...
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Case Study: Quality System Optimization
At QualityHub, we have experience in quality systems for several types of companies and situations. Here are nine examples of...
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Case Study: Warning Letter
At QualityHub, we have experience in warning letters for several types of companies and situations. Here are four examples of...
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Case Study: Consent Decree Projects
At QualityHub, we have experience in consent decrees for several types of companies and situations. Here are two examples of...
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Case Study: Staff Augmentation Program
At QualityHub, we have experience in staff augmentation for several types of companies and roles. Here are four examples of...
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