Corrective and Preventive Action – Background & Examples
Taking Action • Identify solutions. • Develop action plan for corrective action and/or preventive action. • Should consider the risk posed by the problem. – Not all problems require the same level of investigation and action. – It is appropriate to …
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FDA Medical Device Industry Coalition
fmdic.orgISO 14971: Overview of the standard April 2, 2010 William Hyman, Sc.D. 1 FDA Medical Device Industry Coalition ISO 14971: Overview of the standard
Medical Device Reporting (MDR) 21 CFR Part 803
fmdic.org11 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
Complaints and Complaint Investigations
fmdic.orgComplaints and Complaint Investigations Presented by: Graham N. Giesen, Supervisory Investigator Food and Drug Administration Office of Regulatory Affairs
DEALING WITH FDA 483’s, WARNING LETTERS, and …
fmdic.orgFDA Medical Device Industry Coalition DEALING WITH FDA 483’s, WARNING LETTERS, and OTHER ENFORCEMENT ACTIONS Presented by: David Furr Principal Consultant, FDC Services, LLC
Safety and Performance Grading of Quality …
fmdic.orgSafety and Performance Grading of Quality Management System Non-conformities CAPT Kimberly Lewandowski -Walker FDA/ORA/Office of Medical Products and
MDR: Failures, Successes and Solutions
fmdic.orgFDA Medical Device Industry Coalition MDR: Failures, Successes and Solutions Scott Eden, Sr. Director Quality and Regulatory
US Food and Drug Administration - FDA Medical …
fmdic.orgAn Educational Forum co-sponsored by the US Food and Drug Administration and the FDA Medical Device Industry Coalition April 2, 2010 Arlington, Texas USA
Medical Device Single Audit Program
fmdic.org1 Medical Device Single Audit Program CAPT Kimberly Lewandowski-Walker . FDA/ORA/Office of Medical Products and Tobacco Operations . National Expert, Medical Devices
Corrective and Preventive Action – Background & Examples
fmdic.org•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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