Fda audit - PowerPoint PPT Presentation

Auditing for Compliance

Auditing for Compliance. It is important to periodically do self-inspections to assure that your policies, practices, procedures, etc. meet the minimum cGMP requirements. 1. Internal Audit Program. Trained auditors Know the regulations and requirements Report what they see

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1.25k views • 25 slides

Research/Regulatory Support Services

Research/Regulatory Support Services. Workgroup participants : Karen Hartman , Operations Manager, Office of Research Regulatory Support Cheryl Nelson , Associate Director - Administration, Mayo Clinic Center for Translational Science Activities (CTSA); Administrator, Research Operations

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282 views • 18 slides

Response to FDA Audit 483 MX-4501N 20100317 114032 3-10 : Nine Category 483 Citations Meetings

FDA Audit Citations – March 2010. Response to FDA Audit 483 MX-4501N 20100317 114032 3-10 : Nine Category 483 Citations Meetings Minutes : Votes for, against, abstention and reason not recorded; controverted [sic: controversial] discussions not summarized

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197 views • 8 slides

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