Quality is not an Organization

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

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

"Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma"

What does Quality mean to you?

Description

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

This webinar will help you understand the various interpretations. We will discuss concepts for creating a culture of quality and management excellence with your company.

Why should you Attend

Every organization has stakeholders. Your customers demand safe and effective medical devices. The regulators expect you to follow the regulations for your markets with resulting product quality and compliance.

And your business can't survive without efficient and effective processes to manage scarce resources. This webinar can help you balance and meet all of those expectations. You will learn how to create a culture of quality that can be a competitive advantage

Learning Objectives

•      Warning signals that indicate quality problems within your organization
•      Changing your organization form reactive to proactive
•      How a culture of quality and compliance can impact your company success
•      The risks your company faces from quality and compliance issues
•      Creating a culture of quality and compliance at all levels of your organization

Areas Covered

•      FDA and NB expectations for Quality Systems
•      Lessons Learned from 483s and warning letters
•      How culture can impact quality and compliance risk
•      Management commitment and responsibility
•      Maturity levels to understand your culture of quality
•      Roles and responsibilities
•      The case for quality
•      Stages of quality and compliance culture
•      Tools and techniques for improvement
•      Best Practices

Who will Benefit

•      Quality Systems Specialists
•      Quality and Compliance Specialists
•      Internal Auditors and Managers
•      Training Specialists
•      CAPA Specialists
•      Management Representatives
•      Quality/Compliance Managers or Directors for Medical Device Companies
•      General Managers wanting to Learn how to understand Quality System Requirements

Industries who can attend

This 90-minute 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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