MSS 01DEC06 1 Compliance Activities 2006 New England District Office FDA CAPT Mutahar Shamsi, USPHS Director, Compliance Branch

Slides:

Advertisements

Similar presentations

Basic Principles of GMP

Advertisements

FDA QS reg/CLIA Comparison: Overview

FDA Medical Device Enforcement and Quality System Update

CAPA Best Practices Open Discussion

Building a Cradle-to-Grave Approach with Your Design Documentation and Data Denise D. Dion, EduQuest, Inc. and Gina To, Breathe Technologies, Inc.

What FDA Looks for When Inspecting IRBs and Sponsors Marian J. Serge Nurse Consultant Division of Bioresearch Monitoring Office of Compliance Center for.

Good Manufacturing Practice Regulations

1 Introduction to Safety Management April Objective The objective of this presentation is to highlight some of the basic elements of Safety Management.

EMS Checklist (ISO model)

21 CFR Part 11 course syllabus / Ilan Shaya 21CFR Pat 11 | Objective | Audience |Course Outline | Details 15-16/7/2013.

Biopharmaceutical Quality

Sorenson Medical, West Jordan, Utah USA Medical Device Development Robert Hitchcock, Ph.D. Director of Engineering & Technology Development Sorenson Medical,

U.S. FDA Approach to Auditing Including QSIT

Device Initiatives FY 2005 Karen A. Coleman FDA Device National Expert.

REGULATIONS for SUPPLIES, EQUIPMENT, REAGENTS and TESTING JILL HOAG BS, SBB(ASCP) CQA(ASQ) AABB STAFF LEAD ASSESSOR 1.

Overview of FDA Device Regulations

Checking & Corrective Action

Environmental Management Systems Refresher

Radiopharmaceutical Production

Regulatory Auditing. Audit Areas Management Responsibility Auditing (internal and external) Design Control Document Control Purchasing Control Identification.

Who is Responsible?. 2 Course Objectives  Help you decide that safety IS everybody’s business and why  Provide you with an understanding of accident.

PREPARATION FOR FDA INSPECTION

 Contracts  Subcontracting  Suppliers  Complaints  Corrective and preventive actions (CAPA)  Internal audits  Management reviews Management requirements.

Metric, Data and Analysis Biometrics Ricki A. Chase Director, Investigations Branch

21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004 NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION.

FIELD COMPLIANCE UPDATE CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO.

Pre-Market and the QSR Presented by: Dawn Fernandes.

Total Product Life Cycle An Example. Medcon May 2, Agenda Post Market Surveillance Total Product Life Cycle and Product Design Systematic Collection.

QC/QA Mary Malarkey Director, Division of Case Management Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research March.

Session 6: Data Integrity and Inspection of e-Clinical Computerized Systems May 15, 2011 | Beijing, China Kim Nitahara Principal Consultant and CEO META.

QSIT Management Controls QSIT Workshops. Management Controls u Importance u Assessment u Demonstration of Compliance.

Regulatory Update Ellen Leinfuss SVP, Life Sciences.

Auditing for Compliance

Evolving IT Framework Standards (Compliance and IT)

Good Manufacturing Practices

Inspection Issues in the Analytical Laboratory: An FDA Perspective Yvonne McKnight Chemist US Food and Drug AdministrationPhone: x

Top 10 Medical Device Citations

Lecture Topic 4: Good Manufacturing Practices (GMPs)

Kimberly A. Trautman FDA’s Medical Device Quality System Expert

This class cannot be shared or copied without the written permission of PracticeWorks Systems, LLC.

QSR and GLP What exactly are these?.

Resource Management Resource Management 3.03 Understand support services.

New England District Update MassMEDIC Conference December 1, 2010 Waltham, MA.

A QUALITY IMPROVEMENT TOOL

1 Beth Staub and Joseph Sapiente FDA Case for Quality.

The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Presented by J. Glenn George Thursday, March 29, 2007 Day II – Track.

INTRODUCTION Quality System in Medical Devices ©2014 Salt Lake Community College. All rights reserved.

Complaint Handling Medical Device Reporting May 19, 2016 Rita Harden, Director Customer Relations & Regulatory Reporting.

Device regulations USA Dr Phil Warner. USA Regulations MEDICAL DEVICES Food, Drug & Cosmetics Act Medical Device Amendments of 1976 (and other things)

November 6, 2013 Purchasing Controls & Supplier Quality Best Practices Beyond Compliance for the Medical Device Industry AdvaMed 2013 Bernie Liebler Technology.

eQMS Implementation at CoorsTek Medical

Resource Management 3.03 Understand support services

The Quality System Inspection Technique (QSIT)

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Presented by: Ken Glade Director of Engineering

FDA Quality System Regulation

How to Respond to a Corporate Warning Letter John M Taylor

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Audit Criteria Organisation Factors (chair – LI Xiang) QMS Funding

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Resource Management 3.03 Understand support services

Warning Letters – The Forgotten Five

New England District Update

Radiopharmaceutical Production

Presentation transcript:

MSS 01DEC06 1 Compliance Activities 2006 New England District Office FDA CAPT Mutahar Shamsi, USPHS Director, Compliance Branch

MSS 01DEC062 Top 5 Device 483 Cites Top 5 Device 483 Cites CFR (a), maintain Complaint files 2. 21CFR (a), establish Corrective & preventive action procedures CFR , written MDR procedures 4. 21CFR820.75(a), Process validation 5. 21CFR (b), document Corrective & preventive action 5. 21CFR820.22, Quality audit procedures; Management w/ executive responsibility(2005)

MSS 01DEC Top 5 NWE-DO Device 483 Cites 1. 21CFR820.22, Quality audit 2. 21CFR820.25(b), Training documentation 3. 21CFR (a), maintain Complaint files 4. 21CFR (b), document Corrective & preventive action 5. 21CFR (a), establish Corrective & preventive action

MSS 01DEC Top 5 NWE-DO Device 483 Cites 1. 21CFR (b), document Corrective & preventive action 2. 21CFR (a), maintain Complaint files 3. 21CFR820.22, Quality audit 4. 21CFR (a) establish Corrective & preventive action

MSS 01DEC Top 5 NWE-DO Device 483 Cites 5. 21CFR820.25(b) establish Training procedures; 21CFR803.50(a)(2), MDRs malfunctions; 21CFR (b), document Corrective & preventive action; 21CFR (a)(3), MDR evaluation

MSS 01DEC NWE-DO Device Cites by Section 1. Corrective & preventive action 2. Quality audit 3. Complaint files 4. Medical Device Reporting 5. Personnel; Receiving, in-process, & finished device acceptance

MSS 01DEC NWE-DO Device Cites by Section 1. Corrective & preventive action 2. Complaint files 3. Receiving, in-process, & finished device acceptance 4. Production & process controls 5. Medical Device Reporting

MSS 01DEC068 Summary 483s FDA – Wide NWE-DO CitesSections (a)22100(b) CAPA (100) 100(a)25(b)198(a) Quality Audit (22) Complaints (198) (a)22 Recv (80) 75(a)100(b)100(a) MDRs (803) P&PC (70) 100(b)/ 22 (2005) 100(a) 25(b), (a)(2),1 00(b)198(a )(3) Recv (80); Personnel (25) MDRs (803)

MSS 01DEC069 Actions 1 Seizure 1 Seizure Unapproved device Unapproved device Did not meet performance standard Did not meet performance standard Mislabeled Mislabeled Unregistered facility Unregistered facility

MSS 01DEC0610 Actions 3 Warning Letters 3 Warning Letters 1.Corporate – wide 2.Recidivist 3.QSR + MDR + Corrections & Removals

MSS 01DEC0611 Actions Imports Imports Detained Detained Examination gloves (GMPs, holes) Examination gloves (GMPs, holes) Bandages (GMPs) Bandages (GMPs) Xray equipment (no 510(k)) Xray equipment (no 510(k)) UV lamp (no accession #) UV lamp (no accession #) Refused Refused Examination gloves (holes) Examination gloves (holes)