Quality Management System Seminar 2018 | How to go from Surviving to Thriving

GlobalCompliancePanel

Course

In Fremont (USA)

£ 1,192.29 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

The best Medicine courses

See all

See all

Description

  • Type

    Course

  • Location

    Fremont (USA)

  • Class hours

    9h

  • Duration

    2 Days

Essentials of an effective QMS

Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress.

Facilities

Location

Start date

Fremont (USA)
See map
161 Mission Falls Lane, 94539

Start date

On request

About this course


Essentials of an effective QMS
Essentials of an efficient QMS
Quality is not an Organization
Key Capabilities
Maturity Modeling
Vision, Strategy, and Quality Planning
Improvement Tools
Best Practices


Quality Systems Specialists
Quality and Compliance Specialists
Auditors
Quality and Compliance Managers and Directors
CAPA Specialists
Project Managers
Supplier Quality Engineers and Auditors
Quality Engineers
Management Representatives
General Managers

Questions & Answers

Add your question

Our advisors and other users will be able to reply to you

Who would you like to address this question to?

Fill in your details to get a reply

We will only publish your name and question

Reviews

Subjects

  • Quality
  • Quality management
  • Quality Training
  • Healthcare
  • Medical training
  • Medical
  • Pharma
  • Regulatory
  • Compliance
  • Fda

Teachers and trainers (1)

Susanne Manz Susanne Manz

Susanne Manz Susanne Manz

Quality and Compliance Expert / Auditor for Medical Devices, Manz Cons

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 industry leaders like 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.

Course programme

Day 1 Schedule

Lecture 1:

  • Regulatory expectations for a QMS
  • Lessons Learned from 483s and warning letters
  • Common problems and simple solutions

Lecture 2:

  • QMS Structure
  • Roles and Responsibilities

Lecture 3:

  • Management Responsibility, Culture of Quality, Risk Management

Lecture 4:

  • Key Capabilities for success
  • Maturity Modeling
  • QMS Evolution
Day 2 Schedule

Lecture 1:

  • Metrics, internal Audit
  • Cost of Quality

Lecture 2:

  • Quality Leadership

Lecture 3:

  • Vision and Strategy
  • Quality Planning

Lecture 4:

  • Improvement Tools and Techniques
  • CAPA and RCA

See related categories

Quality Management System Seminar 2018 | How to go from Surviving to Thriving

£ 1,192.29 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

The best Medicine courses

See all

See all