Bulletproof CAPA Handling and Investigations for Medical Devices

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

13. FDA CAPA Warning Letter issues and root cause determinations
14. CAPA procedural requirements
15. Defining a Threshold to open a CAPA
1. Complaints
2. Nonconformance
3. Trending
16. Opening a CAPA
17. The CAPA Investigation
1. Plan and Execution
18. The Root Cause Investigation
1. The 5 Why’s;
2. Fishbone diagram;
3. Pareto charts;
4. Process mapping;
5. Fault Tree Analysis (FTA)
19. Risk Analysis
20. The CAPA Plan
1. Establishing
2. Relating a plan to each identified Root Cause identified
21. CAPA Plan Execution
22. The Verification of Effectiveness
1. Plan and execution
23. CAPA documentation expectations
24. CAPA reviews approvals
25. CAPA closure
26. CAPA Case Study Exercise from current FDA Warning Letters

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.