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Readying for a US FDA Inspection
Readying for a US FDA Inspection Home » Compliance Tips » Readying for a US FDA Inspection If your company produces drugs, medical devices or nutraceuticals that fall under US cGMP reg...
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What You Need to Know About Vendor Audits
What You Need to Know About Vendor Audits Home » Compliance Tips » What You Need to Know About Vendor Audits A vendor audit is a vehicle used by pharmaceutical companies, and other lar...
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Ensuring Effective SOPs in the Pharmaceutical Industry
Ensuring Effective SOPs in the Pharmaceutical Industry Home » Compliance Tips » Ensuring Effective SOPs in the Pharmaceutical Industry Every year, FDA hands out plenty of 483s and warn...
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21 CFR 820.198 – Implementing Risk-Based Management in Handling Complaints
21 CFR 820.198 – Implementing Risk-Based Management in Handling Complaints Home » Compliance Tips » 21 CFR 820.198 – Implementing Risk-Based Management in Handling Complaints CFR 820.1...
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FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis Home » Compliance Tips » FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis When FDA arrive...