Course Description:

FDA's findings of Medical Device company Quality System Regulation (QSR) deficiencies in 2012 fall into four areas, of which two are especially prominent: Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC), both of which accounted for 30% of all cited deficiencies. Between January 2012 and May 2013, FDA issued 126 Medical Device Warning Letters containing noted CAPA deficiencies.

The average cost of a Warning Letter remediation effort is estimated at US $750,000 in order to correct the FDA identified deficiencies including added resources for consultants, personnel, remediation of legacy records, etc. This cost estimate does not even include the ramifications of product recalls or holds, cost of not going to market with a new device, or delays in FDA 510(k) or PMA (Premarket approval) as a result of a Warning Letter.

The cost of FDA non-compliance is therefore WAY more than the cost of compliance. Are you in compliance with the FDA CAPA regulations for medical devices?

In this two day workshop conference you will learn how to use the FDA Quality System Inspection Technique (QSIT) and methods of problem solving in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practice CAPA Systems to provide thoughts and ideas to improve the performance of your current system. Additionally, case studies will explore how your CAPA management practices can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators (FDA) and Auditors.

Seminar instructor Lori A Carr is an ex- FDA official having spent more than 12 years with the FDA as a Medical Device Specialist, Medical Device Registration Monitor and also as a member of the FDA Foreign Inspection Cadre for Medical Devices. She was an FDA Level II Certified Medical Device Investigator which is a special honor that was bestowed on FDA Investigators who were able to demonstrate competence in conducting inspections in the Medical Device Program area.

Learning Objectives:

Upon completing this course participants should:

  • Understand how FDA inspects CAPA to QSIT (Quality System Inspectional Technique)
  • Utilize FDA inspectional techniques to identify and implement the main ingredients of a good CAPA system
  • Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions
  • Receive a tool box of methods to assist you in knowing if you have a comprehensive, bullet proof CAPA System
  • To investigate true root causes of problems and to evaluate and prioritize solutions
  • Problem solving methods to help you asses which is best for your situation
  • Develop successful implementation plans
  • Differentiate between corrective and preventative actions
  • Understand where an issue can be localized or must be evaluated for systemic effect
  • Perform risk assessments effectively
  • Understand where companies miss the mark in triggering, investigating and executing CAPAs

Who will Benefit:

This course is designed for people tasked with maintaining and improving 21 CFR 820 Quality Systems for medical device manufacturers. This includes individuals that have ISO 9001/AS9100/TS 16949/ISO13485 Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to Corrective and Preventive Actions (CAPA). Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal Professionals

Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. CAPA Process Overview
  2. FDA Quality System Inspection Technique (QSIT)
  3. CAPA handling
    1. How FDA inspects CAPA to QSIT?
  4. The FDA Inspection Breakdown
  5. Main ingredients to a good CAPA system
    1. Tips and pitfalls
      1. CAPA Process, Infrastructure, and System
    2. CAPA Inputs
      1. Internal Sources, External Sources, and Outputs
  6. FDA Inspection Techniques
  7. What is FDA looking for?
    1. CAPA data source
    2. Complaint and MDRs
    3. Corrections and Removals
    4. Risk Management
  8. System wide deficiencies
  9. Ideal CAPA characteristics and CAPA Record
    1. People, process, tools
  10. The Ideal CAPA record
  11. How to Handle the FDA CAPA inspection
  12. The Law Perspective and Risk Analysis

  1. FDA CAPA Warning Letter issues and root cause determinations
  2. CAPA procedural requirements
  3. Defining a Threshold to open a CAPA
    1. Complaints
    2. Nonconformance
    3. Trending
  4. Opening a CAPA
  5. The CAPA Investigation
    1. Plan and Execution
  6. The Root Cause Investigation
    1. The 5 Why’s;
    2. Fishbone diagram;
    3. Pareto charts;
    4. Process mapping;
    5. Fault Tree Analysis (FTA)
  7. Risk Analysis
  8. The CAPA Plan
    1. Establishing
    2. Relating a plan to each identified Root Cause identified
  9. CAPA Plan Execution
  10. The Verification of Effectiveness
    1. Plan and execution
  11. CAPA documentation expectations
  12. CAPA reviews approvals
  13. CAPA closure
  14. CAPA Case Study Exercise from current FDA Warning Letters

Meet Your Instructor

Lori A Carr, RAC, CQA
FDA Medical Device Regulatory and Quality Consultant

Lori Carr, RAC, CQA is President and CEO of Lori A. Carr, Inc., is a Principal Consultant in the Medical Device regulated industry. She has 19 years of experience in this field. In her Regulatory Affairs consulting practice, including mock FDA inspections/audits, gap analysis, and compliance remediation activities associated with all aspects of medical device manufacturing, Ms. Carr brings 13 years of FDA Medical Device Specialist/Investigator experience.

She began her FDA career in 1994 in the Cincinnati District Office and transferred to the Denver District Office in 2001 as a Medical Device Specialist. In both FDA locations, she acted as the FDA Medical Device Registration Monitor and was also a member of the FDA Foreign Inspection Cadre for Medical Devices in which she conducted foreign Good Manufacturing Practice (GMP) and Quality System Regulation (QSR) inspections for routine, premarket (including 510(k) and PMAs) and post-market inspections. She was an FDA Level II Certified Medical Device Investigator which is a special honor that was bestowed on FDA Investigators who were able to demonstrate competence in conducting inspections in the Medical Device Program area.

Her general medical device inspectional work experience includes the firm types as follows: foreign and domestic; pre-market and post-market; Class I, Class II, and Class III; high risk; routine and directed; and contract gamma, electron beam, and ethylene oxide sterilization facilities. In this role, she inspected domestic and international medical device companies to compliance with FDA’s regulation for medical devices (21 CFR 820). She has provided training during the FDA National Basic Medical Device School which trains FDA Medical Device Investigators and to numerous industry groups on various medical device topics including 21 CFR 820, QSIT, CAPA, internal auditing, statistical techniques, sampling, Production and Process Controls, sterilization, FDA inspectional readiness, etc.

She began Regulatory consulting for the medical device industry in March 2007. In her capacity as a regulatory consultant, she assists firms in conducting internal Quality System Audits, assessing the gaps within the Quality System, setting up compliant Quality Systems and in remediating FDA Warning Letter and Injunction/Consent Decree situations.

Her Professional Certifications include the Regulatory Affairs Certification (RAC/US) through the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) through American Society for Quality (ASQ). She also holds a BS degree in Chemistry from Xavier University in Cincinnati, Ohio.

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