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Zuhdi Hussein

Recent Posts

10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by Zuhdi Hussein

The CAPA process from the side of regulatory compliance of both U.S. FDA. [...] Read More

Posted in Medical Device Quality Management Systems

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by Zuhdi Hussein

Data integrity is an ever-increasing concern in life sciences, with medical. [...] Read More

Posted in Quality Management Systems

How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by Zuhdi Hussein

You know which rules you're responsible for following, but is that enough?. [...] Read More

Posted in supplier audits

The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by Zuhdi Hussein

Pharmaceutical manufacturers can't sell their products without first convincing. [...] Read More

Posted in Prescription Drug Users Fee Act

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by Zuhdi Hussein

How do your compliance efforts impact the profitability of the goods you. [...] Read More

Posted in FDA Medical Device Compliance

How Compliant Are Your Medical Devices with EU Cloud Computing Regulations?

February 4th, 2015 by Zuhdi Hussein

Cloud computing architectures vary widely. In addition to incorporating tons of. [...] Read More

Posted in Medical Device EU Guidelines

Is It Time for Your Firm to Undergo an FDA Mock Audit?

January 19th, 2015 by Zuhdi Hussein

Among compliance tools, FDA mock audits are undeniably useful. By giving. [...] Read More

Posted in Quality Management Systems

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by Zuhdi Hussein

FDA gap analysis helps organizations quantify the differences between their. [...] Read More

Posted in SOPs

Are You Ready to Become Compliant With EU Annex 11?

October 8th, 2014 by Zuhdi Hussein

If you engage in GMP-regulated actions, use computers in any facility and wish. [...] Read More

Posted in GxP CC

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by Zuhdi Hussein

Regulatory compliance is important for any life-sciences firm, but the breadth. [...] Read More

Posted in GxP CC

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