6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
Product Id : 10454
Price Details
This 6-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.
We’ll discuss 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.
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. 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.
Learning Objectives
- Understand the regulatory requirements
- 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 preparedness
Who Will Benefit
- 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
Using lecture, discussion, case studies, and break-out groups, this 2-day seminar will provide you with the tools to create an effective and efficient CAPA program. Topics to be covered include:
- FDA expectations for CAPA
- Lessons Learned from 483s and warning letters
- Common problems with CAPA
- Elements of a CAPA program
- How to structure your CAPA process
- How to use IT tools 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
She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.