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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
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
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
Corrective and Preventive Action – Background & …
fmdic.orgCorrective and Preventive Action – Background & Examples Presented by: Kimberly Lewandowski-Walker Food and Drug Administration …
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
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