Webinar Takeaway

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

Join us for a webinar on March 11 for a discussion of the webinar.

This 90-minute webinar will cover:

  • 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

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

Who Will Benefit

  • Quality Systems Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • Management Representatives
  • Quality and Compliance Leaders
  • Quality/Compliance managers or directors for Medical Device companies
  • General Managers wanting to learn how to understand Quality System requirements

Overview

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.

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.


Susanne Manz

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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 

Choose a Purchase Option


$199

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 90-minute webinar for all the participant, presentation materials , MP3 Download and the opportunity to ask questions by phone and email

$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$289

Live + Recorded Access - Single Participant

You get one log-in for the live & recorded 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email