Las Vegas Events

Does your CAPA Program Need a CAPA | Seminar CAPA 2018

Thursday

May 3, 2018 – 9:00 AM - 6:00 PM

7250 Pollock Drive
Las Vegas, NV 89119 Map

More Info

Course "Death by CAPA - Does your CAPA Program need a CAPA?" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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.
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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
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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
Agenda:
Day 1 Schedule
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Lecture 1:
• FDA expectations for CAPA
• Lessons Learned from 483s and warning letters
• Common problems with CAPA
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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
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Lecture 3:
• A toolkit for CAPAs
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Lecture 4:
• Sources of Data
• Analysis of Data
• Failure Investigation
Day 2 Schedule
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Lecture 1:
• Root Cause Analysis
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Lecture 2:
• CAPA Project Management
• Problem Solving and Improvement techniques
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Lecture 3:
• Effectiveness Checks
• Control, Monitoring, Dissemination of Information
• Connections within your Quality Management System
o Non-conforming Product
o Corrections and Removals
o Change Control
o Statistical Techniques
o Risk Management
• Bullet-proof Reports
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Lecture 4:
• Inspection Readiness and Checklist
• Best Practices
Speaker
Susanne Manz
Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.


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.

Location: Las Vegas, Nevada Date: May 3rd & 4th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Las Vegas Airport 7250 Pollock Drive Las Vegas, NV USA 89119
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,295.00 From April 01 to May 01, Regular Price: $1,495.00
Sponsorship Program benefits for “Does your CAPA Program Need a CAPA | Seminar CAPA 2018”
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901663SEMINAR?SEO-eventbrite-may18
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Price: Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird) Until March 31, Early Bird Price: $1,295.00 From April 01 to May 01, Regular Price: $1,495.00

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