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Metric, Data and Analysis Biometrics Ricki A. Chase Director, Investigations Branch
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 (d) 21 CFR (b) 21 CFR (b) 21 CFR CFR (a)
Pharma Inspectional Specifics Total Inspections Classified OAI – – Drug Manufacturing – A – Sterile Drugs – F – API – H – Abbreviated Drug EI – B – Drug Repackers/Relabelers
Device Observation Trends CAPA Procedures MDR Procedures CAPA Activities Process Validation Complaint Handling 21 CFR (a) 21 CFR CFR (b) 21 CFR (a) 21 CFR (a)
Device Inspectional Specifics Total Inspections Classified OAI – B – Full QSIT – C – Compliance Inspection – A – Abbreviated QSIT – G – For Cause – S – Sterile Device – – MDR – R – Corrections/Removals
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FDA Compliance Enforcement Actions: What you need to know for clinical device trials The 3 rd Annual FDA Regulatory and Compliance Symposium Track 3- Pharma.
1 Drug Quality in the 21 st Century Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research May 11, 2010.
Managing the Risk of Organisational Accidents Peter Cuffe Chief Safety & Security Officer Irish Rail International.
Quality Systems Compliance 1 FDA Medical Device Quality Systems Compliance.
Validation | Slide 1 of 39 August 2006 Validation Supplementary Training Modules on Good Manufacturing Practice WHO Technical Report Series, No. 937, 2006.
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Quality Systems and Risk Management Approaches for Networked Drug Development David A. Moyer VP, Regulatory Compliance Programs Fulcrum Pharma Developments,
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Feed Manufacturing & Distribution Requirements Including Good Manufacturing Practices (GMPs) Brenda Ball Compliance Manager AZ Department of Agriculture.
What FDA Looks for When Inspecting IRBs and Sponsors Marian J. Serge Nurse Consultant Division of Bioresearch Monitoring Office of Compliance Center for.
Executive Management and Quality Systems Awareness Gordon B. Richman Vice President, EduQuest, Inc. EduQuest Education: Quality Engineering, Science &
©Ian Sommerville 2000Software Engineering, 6th edition. Chapter 25 Slide 1 Chapter 25 Process Improvement.
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