Live Webinar Continuous Improvement Tools for your Quality Management System

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Description

May 10,2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

This webinar will explore tools for improving your Quality Management System. CAPA (Corrective and Preventive Action), Root Cause Analysis, Risk Assessment, Six Sigma, Management Review and more are processes that should be in your Quality Management System. Many companies have weak processes or understand these processes individually but they don’t know how to put them together into an efficient and effective program for continuous improvement. So, they continue to try new things in the hope that they will find something that sticks.

In this webinar, we will discuss how to create a comprehensive system for continuous improvement including:
• Techniques to identify and prioritize risks
• Improvement methods with pros and cons
• Root Cause Analysis overview
• Project and change Management
• Control and monitoring

Why Should You Attend

Continuous Improvement is a system of processes and tools to identify, prioritize, analyze, improve, control and monitor activities. Weakness in any of these areas can lead inefficiency and ineffectiveness of the whole system. This webinar will explore how these areas are connected and how they best work together.
Topics:

Areas Covered

•   Using a structured program to identify problems and opportunities for improvement
•   How a culture of quality and compliance can encourage clear and transparent communication of risk.
•   How to prioritize, resource, and implement corrective actions.
•   Root Cause Analysis overview.
•   Tools for monitoring and communicating risk and improvement over time.
•   How to identify residual risk.
•   Monitoring and Controlling progress over time.
•   Signs that your company culture is taking unnecessary compliance or quality risk.
•   How to ensure management gets valuable information to enable adequate prioritization and resourcing
•   How to prioritize, resource, and implement corrective actions.
•   Tools for monitoring and communicating risk and improvement over time.

Who will Benefit

•   Quality Systems Specialists
•   Document Control Specialists
•   Quality and Compliance Specialists
•   Auditors
•   Auditor Managers
•   Supplier Auditors
•   Training Specialists
•   CAPA Specialists
•   Quality/Compliance leaders, managers, or directors for Medical Device companies
•   General Managers wanting to learn about effective Management Review

Industries who can attend

This online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Susanne Manz

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, WW Director of Quality Engineering and, 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. 

Specialties: Quality, Compliance, Six Sigma, Lean Sigma, Quality Systems Development, ISO13485, ISO14971, GMP, QSR, CFR820, Quality Systems Auditing, Supplier Audits, Due Diligence, Predictive Compliance,Training and Education, FDA and Notified Body Inspection Readiness, Risk Management and Mitigation, Management Review, Quality Improvement, Supplier Management, Supplier Auditing, Process Validation, Problem Resolution, 483 / Warning Letter responses and mitigation.

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