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Metric, Data and Analysis Biometrics Ricki A. Chase Director, Investigations Branch email@example.com 312-596-4240
Center Work Planning District Work Planning Factors Driving Frequency Unplanned Work Data What’s New
Center Work Planning (CDER) –Process and Communication between CDER and ORA –CDERs Risk Model –Assignments to the field Focus on change management Compounding Pharmacies
Factors of CDER’s Risk Model (Top Level) –Product Dosage Form Intrinsic Chemical Properties –Facility Poor GMP Compliance History –Process Measuring Mixing Compression Filling
Top Ranked High Risk Product Categories –Biotech –Liquid Sterile Solution –Liquid Sterile Suspension/Emulsion –MDI low active –MDI high active
Poor Compliance History Recalls FARs Warning Letters/Recidivist Under Consent Decree Failure to obtain application
Process Factors Contamination Yield Changeover Cleanability Validation Maintenance
District Work Plan (CDER)
Center Work Planning (CDRH) –District Driven Process –Special Coverage Requests to the Field Data driven directed inspections
CDRH Special Factors Class 1 Inspection Initiative –Increase number of recalls –Inconsistencies in device registration/listing –Better use of resources
District Decision Factors Statutory Requirement to Inspect Classification of Device Compliance History MDRs and Recalls Industry Trends
Unplanned Work Recalls 6 months post regulatory action FARs/MDRs Directed Inspection Request Pre-approvals Consumer Complaints
Pharma Observation Trends QCU Production/Process Control – not followed Lab Controls Batch Discrepancies No P/PC 21 CFR 211.22(d) 21 CFR 211.100(b) 21 CFR 211.160(b) 21 CFR 211.192 21 CFR 211.100(a)
Pharma Inspectional Specifics 2013 537 Total Inspections Classified OAI –81 56002 – Drug Manufacturing –69 56002A – Sterile Drugs –20 56002F – API –6 56002H – Abbreviated Drug EI –5 56002B – Drug Repackers/Relabelers
Device Observation Trends CAPA Procedures MDR Procedures CAPA Activities Process Validation Complaint Handling 21 CFR 820.100(a) 21 CFR 803.17 21 CFR 820.100(b) 21 CFR 820.75(a) 21 CFR 820.198(a)
Device Inspectional Specifics 2013 537 Total Inspections Classified OAI –13182845B – Full QSIT –3082845C – Compliance Inspection –29 82845A – Abbreviated QSIT –2582845G – For Cause –2282845S – Sterile Device –14581001 – MDR –2581845R – Corrections/Removals
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PRODUCT TRANSFER. Scope This scope applies to all Product transfers of marketed : Active Pharmaceutical Ingredient Intermediate Pharmaceutical product.
Important informations Good manufacturing practice (GMP) & Quality Assurance (QA) & Quality control (QC)
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1 ASQ Keynote February 13, 2006 A Look Back at 2006 The year of the hurricane Organizational Change National and District Changes in programs Adverse Drug.
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