Quality Assurance and Quality Risk Management for Drug Importers - ComplianceOnline (QA in drug imports)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

The FDA Globalization Act of 2009 will significantly impact the role of QA and the scope of Quality Risk Management. Prospective source audits and Quality Agreements will be required by the FD&CA. This presentation will examine considerations for the expanded role of QA in drug imports, and the expanded scope of Quality Risk Management relating to drug imports. The potential impact on CMOs, Quality Agreements, and drug pipelines will be discussed

Venue

Additional Information

The FDA Globalization Act of 2009 will significantly impact the role of QA and the scope of Quality Risk Management. Prospective source audits and Quality Agreements will be required by the FD&CA. This presentation will examine considerations for the expanded role of QA in drug imports, and the expanded scope of Quality Risk Management relating to drug imports. The potential impact on CMOs, Quality Agreements, and drug pipelines will be discussed