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This 2-day 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

Course Audience:
  • 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

Day 1 Schedule Lecture 1: FDA expectations for CAPA Lessons Learned from 483s and warning letters Common problems with CAPA Lecture 2: 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 Lecture 3: A toolkit for CAPAs Lecture 4: Sources of Data Analysis of Data Failure Investigation Day 2 Schedule Lecture 1: Root Cause Analysis Lecture 2: CAPA Project Management Problem Solving and Improvement techniques Lecture 3: Effectiveness Checks Control, Monitoring, Dissemination of Information Connections within your Quality Management System Type testing Sample testing Software verification testing Inspections Analyses Bullet-proof Reports Lecture 4: Inspection Readiness and Checklist Best Practices
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Death by CAPA - Does your CAPA Program need a CAPA?
  • Course ID:
  • Duration:
    2 days
  • Price:
  • Date:
    Thursday 5/3/2018
  • Time:
    9:00 am to 6:00 pm
  • Location:
    Las Vegas
    7250 Pollock Drive
    Las Vegas, NV 89119