use this promo code GCP50 to get 50% off. 1 ATTENDEE $2,000. Regular Price: $2000. Register for 1 a...
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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.
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:
Who Will Benefit:
Day 1 Schedule
Day 2 Schedule
o Non-conforming Product
o Corrections and Removals
o Change Control
o Statistical Techniques
o Risk Management
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.
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
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