Seminar on Death by CAPA – Does your CAPA Program need a CAPA?

Start Date : April 18, 2019
End Date : April 19, 2019
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : globalcompliancepanel@gmail.com

Location :
Embassy Suites Boston Logan Airport, 207 Porter St, Boston, MA 02128, USA

Website

Description

 


Description:


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


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


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


o    Non-conforming Product


o    Corrections and Removals


o    Change Control


o    Statistical Techniques


o    Risk Management


·         Bullet-proof Reports


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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. For more information, visit


www.ManzConsultingInc.net.


 


 


Location:  Boston, MA Date: April 18th & 19th, 2019 and Time: 9:00 AM to 6:00 PM


Venue:  Embassy Suites Boston Logan Airport, 207 Porter St, Boston, MA 02128, USA


 


Price:


1 ATTENDEE $2,000, Register for 1 attendee


5 ATTENDEES $10,000, Register for 5 attendees


10 ATTENDEES $20,000, Register for 10 attendees


Until March 10, Early Bird Price: $2,000.00, From March 11 to April 16, Regular Price: $2,200.00


 


Sponsorship Program benefits for seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship


 


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


globalcompliancepanel@gmail.com


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


Website: http://www.globalcompliancepanel.com


 


Registration Link -  https://www.globalcompliancepanel.com/seminar/death-by-CAPA-Does-your-CAPA-program-need-a-CAPA-901954SEMINAR?seo


Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/


Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/


Follow us on Twitter: https://twitter.com/GCPanel


 








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Registration Info

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

globalcompliancepanel@gmail.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

 

Registration Link -  https://www.globalcompliancepanel.com/seminar/death-by-CAPA-Does-your-CAPA-program-need-a-CAPA-901954SEMINAR?seo

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
Embassy Suites Boston Logan Airport

Tel: 800-447-9407
Mobile: 800-447-9407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/seminar/death-by-CAPA-Does-your-CAPA-program-need-a-CAPA-901954SEMINAR?meetings4docs-*SEO


Event Categories: Emergency Medicine, Headache / Migraine, Internal Medicine, and Pulmonary Medicine.




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