Overview:
This 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 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 requirements, 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 seminar will provide 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.
Areas Covered in the Session:
- Regulatory Requirements and expectations
- Elements for creating an efficient and effective CAPA Program
- CAPA process, tools, and techniques
- Linkages throughout the Quality Management System
- Root Cause Analysis
- Metrics, Control, and Monitoring
- Dissemination of Information
- Myths, Challenges, 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
- Management Representatives