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Home » Expert Reference Materials

Expert Reference Materials

Please find listed below a series of useful documents related to inspections:

EMA’s Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2016 (NEW!)

Presentation slides from FDA CDER Compliance and Enforcement Trends, Jan-Aug 2017 (NEW!)

FDA CY2016 Annual FDA Medical Device Quality System Data

FDA presentation on cGMP Inspections for materials and container/closure systems

FDA presentation on cGMP Requirements for Facilities & Equipment

Presentation slides from Focus on cGMPs & FDA Inspections conference: Laboratory controls

Presentation slides from Focus on cGMPs & FDA Inspections conference: Will Your Quality System Meet FDA’s Expectations During an Inspection?

Presentation slides from Focus on cGMPs & FDA Inspections conference: "What To Expect When Being Inspected"

How the FDA Trains and Prepares Investigators

FDA-EMEA Joint Inspections

Preparing for an FDA Preapproval Inspection

Inspection Readiness: A Guide to Preparing Subject Matter Experts to Face the FDA

Preparing for the EU GMP Inspection

Responding to FDA 483s: Strategies for Successfully Obtaining Closeout

Surviving a Japanese Medical Device Inspection

The Complete Guide to Preparing and Managing an Inspection War Room

Negotiating an FDA Import Hold Crisis:Strategies for Challenging FDA Findings

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