Jim Darnell
Director of Remediation at Fdaqrc
Based in Atlanta, United States
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Seniority
Director
Department
Operations
Location
Atlanta
Industry
Pharmaceutical Manufacturing
Company size
70
Contact information
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j•••••••@fdaqrc.com
Phone
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Background
About Jim Darnell
Experience in: cGMP, GXP, GDP, CMO oversight, development and implementation of Quality Systems, API, solid dosage form, liquids, parenterals, vaccines, medical devices, internal and external auditing, process validation, supplier quality management, Cold Chain, product recall, creation of policies and procedures, CAPA, stability programs, PDMA compliance, vendor qualification, interaction with FDA, EU, DEA, Health Canada, ANVISA, US Customs, and ISO Certifying Bodies.
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