Expert Reference Materials
Please find listed below a series of useful documents related to inspections:
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
How the FDA Trains and Prepares Investigators
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
