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Embassy Suites by Hilton Boston at Logan Airport

207 Porter Street

Boston, MA 02128

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Description

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.

In this seminar, we will discuss:

  • Regulatory Expectations
  • How to plan, structure, and implement a quality system
  • Common problems and lessons from 483 and warning letters
  • Red-flags that your QS is not effective
  • Audit for self-awareness
  • Risk analysis and management techniques
  • CAPA, continuous improvement, and six sigma
  • Performance monitoring
  • Culture, Management Responsibility, and maturity
  • Key Quality System elements and linkages

Why should you attend:

This seminar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You'll learn how to plan, structure, and implement a quality system specific for your business needs. We'll explore the capabilities that every medical device company needs to ensure quality products and a compliant quality system. We'll discuss how to create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then will move on to continuous improvement, six sigma, and Corrective and Preventive Action to address issues within your Quality System. You'll learn how to effectively communicate and escalate risk as well as monitor performance and progress.

This seminar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters!

The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years' experience in medical devices. The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic. She has traveled throughout the world developing, auditing, and improving quality systems.


Learning Objectives:

This 2-day seminar will cover the following areas:
  • Quality System Expectations
  • Quality System Structure
  • Strategy and Planning
  • Risk management in your quality system
  • Case for Quality
  • Inspection preparedness and management
  • Monitoring and metrics
  • Creating a quality strategy and plans

Who will benefit:

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Auditors
  • Auditor Managers
  • Compliance Managers
  • Quality Managers
  • CAPA Specialists
  • Quality and Compliance directors for Medical Device companies
  • General Managers and Executives wanting to use Compliance and Quality as a competitive strength


Day 1 Schedule


Lecture 1:

Overview


Lecture 2:

Introductions


Lecture 3:

Regulatory expectations


Lecture 4:

Quality Systems requirements for medical devices


Lecture 5:

Quality System structure and writing SOPs


Lecture 6:

Roles and Responsibilities


Lecture 7:

Management Responsibility and a Culture of Quality


Lecture 8:

Cost of Quality


Lecture 9:

Key Capabilities for Success


Lecture 10:

Metrics and performance monitoring


Lecture 11:

Maturity Modeling

Day 2 Schedule


Lecture 1:

An effective auditing program is a key to self-awareness


Lecture 2:

CAPA and root cause analysis - essentials for improvement


Lecture 3:

Six Sigma for Quality and Compliance


Lecture 4:

Management Review


Lecture 5:

Inspection preparedness and management


Lecture 6:

Red Flags and Warning Signs


Lecture 7:

Best Practices


Lecture 8:

Risk Management for Compliance


Lecture 9:

Creating a strategy and quality plan


Susanne Manz

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 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. She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. 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, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Location

Embassy Suites by Hilton Boston at Logan Airport

207 Porter Street

Boston, MA 02128

View Map

Refund Policy

No Refunds

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