Corrective and Preventive Action – Background & …

FDA Medical Device Industry Coalition

ISO 14971: Overview of the standard April 2, 2010 William Hyman, Sc.D. 1 FDA Medical Device Industry Coalition ISO 14971: Overview of the standard

  Devices, Medical, Industry, Fda medical device industry coalition, Coalition

Medical Device Reporting (MDR) 21 CFR Part 803

11 Manufacturer Reporting Requirements • Individual adverse event reports no later than 30 calendar days after the day you become aware of a reportable death, serious injury, or

  Devices, Medical, Reporting, Injury, Part, Medical device reporting

Complaints and Complaint Investigations

Complaints and Complaint Investigations Presented by: Graham N. Giesen, Supervisory Investigator Food and Drug Administration Office of Regulatory Affairs

  Investigation, Complaints, Complaints and complaint investigations

DEALING WITH FDA 483’s, WARNING LETTERS, and …

FDA Medical Device Industry Coalition DEALING WITH FDA 483’s, WARNING LETTERS, and OTHER ENFORCEMENT ACTIONS Presented by: David Furr Principal Consultant, FDC Services, LLC

  Devices, Enforcement, Medical, Other, Industry, Letter, Action, Warnings, Fda medical device industry coalition, Coalition, Warning letters, And other enforcement actions

Safety and Performance Grading of Quality …

Safety and Performance Grading of Quality Management System Non-conformities CAPT Kimberly Lewandowski -Walker FDA/ORA/Office of Medical Products and

  System, Management, Quality, Quality management system

MDR: Failures, Successes and Solutions

FDA Medical Device Industry Coalition MDR: Failures, Successes and Solutions Scott Eden, Sr. Director Quality and Regulatory

  Solutions, Failure, Successes, Successes and solutions

US Food and Drug Administration - FDA Medical …

An Educational Forum co-sponsored by the US Food and Drug Administration and the FDA Medical Device Industry Coalition April 2, 2010 Arlington, Texas USA

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Medical Device Single Audit Program

1 Medical Device Single Audit Program CAPT Kimberly Lewandowski-Walker . FDA/ORA/Office of Medical Products and Tobacco Operations . National Expert, Medical Devices

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Corrective and Preventive Action – Background & Examples

•Nonconforming Material Reports •Equipment Data •Scrap/Yield Data •Rework Data •Returned Product •Internal Audits •Process Control Data •Acceptance Activities EXTERNAL SOURCES INTERNAL SOURCES

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Certified Pharmaceutical Good Manufacturing …

2.Audit follow-up Use various methods to evaluate and verify the adequacy of corrective actions taken. (Evaluate) 3.Ineffective corrective actions

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Complaints and Complaint Investigations

Complaints and Complaint Investigations Presented by: Graham N. Giesen, Supervisory Investigator Food and Drug Administration Office of Regulatory Affairs

  Investigation, Complaints, Complaints and complaint investigations

Effective Investigations and Corrective Actions(CAPA)

© Copyright, Globepharm Consulting, 2008 11 21CFR820.100 - CAPA §820.100 Corrective and preventive action (a) Each manufacturer shall …

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Applying Risk Management Principles to Drive …

Applying Risk Management Principles to Drive Quality Management System Effectiveness Carlos Monteagudo Director of Quality Assurance Amgen, Inc. PQRI 2nd FDA/PQRI Conference on Advancing Product Quality

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Building an Effective Supplier Control Program

Building an Effective Supplier Control Program: A review of key program elements & their implementation. Jonathan Lee. VP RQCS Medtronic Surgical Technologies

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Conducting Effective OOS or OOT Investigations for ...

Pharma&Biotech Lonza Cologne GmbH, Cologne / June 2013© Lonza Conducting Effective OOS or OOT Investigations for Unexpected Results from the BET Assay

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QUALITY SYSTEMS APPROACH - ipapharma.org

quality systems approach for cgmp implementation 2 contents: 1.why quality systems? - current issues – gmps & qms 2. structure & elements of pharmaceutical quality systems –