The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This webinar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
This seminar will cover regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection.
This virtual seminar provides detailed lectures on all elements of a CAPA program and how they connect to other parts of your Quality Management System. You will learn how to create a CAPA program that results in improved product quality, reduction in compliance issues, and ultimately leads to improved business success.
CAPA is so important that it is always emphasized in FDA inspections. It is consistently one of the top reasons for 483 and Warning Letter observations. Without an effective CAPA process, it is impossible to have an effective Quality Management System. It is critical that your company establishes a compliant, effective process. This seminar will also provide tools and checklists to ensure your program is inspection ready.
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
This seminar will cover regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection.
This virtual seminar provides detailed lectures on all elements of a CAPA program and how they connect to other parts of your Quality Management System. You will learn how to create a CAPA program that results in improved product quality, reduction in compliance issues, and ultimately leads to improved business success.
Why you should attend
Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain an effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient CAPA system leads to wasted time and resources. In many companies, CAPA becomes a bureaucratic and cumbersome process without yielding desired improvement. This is known as “death by CAPA”. This 4 hour virtual seminar will help you to avoid death by CAPA and turn CAPA into the important improvement process it is meant to be.CAPA is so important that it is always emphasized in FDA inspections. It is consistently one of the top reasons for 483 and Warning Letter observations. Without an effective CAPA process, it is impossible to have an effective Quality Management System. It is critical that your company establishes a compliant, effective process. This seminar will also provide tools and checklists to ensure your program is inspection ready.
Areas Covered in the Session
- Understand the regulatory requirements and the upcoming change to the QSR
- Elements of creating an efficient and effective program
- CAPA process, tools, and techniques
- Linkages to your Quality Management System
- Myths, Challenges, and Best Practices
- Inspection readiness
Agenda
This 4-hour virtual seminar will provide you with the tools to create an effective and efficient CAPA program. Topics to be covered include:- FDA requirements for CAPA
- Differences between QSR and ISO13485 for CAPA
- Lessons Learned from warning letters
- Common problems with CAPA
- Elements of an effective CAPA program
- How to structure your CAPA process
- How to monitor and maintain your CAPAs
- Metrics to ensure your CAPAs are timely and effective
- A toolkit for CAPAs
- Sources of Data
- Analysis of Data
- Failure Investigation
- Root Cause Analysis
- CAPA Project Management
- Problem Solving and Improvement techniques
- Effectiveness Checks
- Control, Monitoring, Dissemination of Information
- Connections within your Quality Management System
- Non-conforming Product
- Corrections and Removals
- Change Control
- Statistical Techniques
- Risk Management
- Bullet-proof Reports
- Inspection Readiness and Checklist
- Best Practices
Speaker
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.Who Should Attend
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Quality Engineers
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- CAPA Managers
- Supplier Quality Engineers and Auditors
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements
