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Zurich 2017 - Medical Device Manufacturing Conference

Monday, Apr 10, 2017 at 9:00AM - Tuesday, Apr 11, 2017 at 6:00PM

Zurich, Switzerland

  • Apr 2017

    10 Mon


  • Apr 2017

    11 Tue


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Zurich 2017 - Medical Device Manufacturing Conference

Monday, Apr 10, 2017 at 9:00AM - Tuesday, Apr 11, 2017 at 6:00PM

Zurich, AR

No tickets available


Supplier selection and management
is one of the critical issues for medical device manufacturers. Suppliers
provide materials and services to the device manufacturer, which means that
they can be critical to performance and delivery of your device. Neither the
FDA nor your notified body regulates your suppliers (with a few exceptions).
They expect you to have an effective process to ensure your suppliers perform
in the regulatory environment.

How well do you understand the
requirements for supplier management?

Could you pass a regulatory audit
or inspection without any issues?

This course delivers the tools,
templates, and methods to help participants implement an effective and
efficient supplier management program.

This two-day hands-on course
provides a clear understanding of the underlying principles of supplier
management. The course uses exercises to solidify understanding. In addition,
the course uses FDA Warning Letters to illustrate the points and help you learn
from others. As part of the practical implementation, the course includes
receiving acceptance activities, outsourced processes, process validation at
the suppliers' location, supplier auditing techniques, and supplier issues in
management review.

The course uses the Global
Harmonization Task Force (GHTF) framework, but expands it to cover other issues
and techniques important in effective implementation.

Why should
you attend:

Since FDA regulations do not allow them to audit your
suppliers unless they make finished medical devices, they require that you have
sufficient control over them. But from time to time the FDA makes a
reinterpretation of what this means. This happened within the last f 5 years,
so if you supplier management program is older than that, you need to make
major changes in you supplier management program. This is why the Good
Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C
stands for current, meaning what the FDA considers the current state of the art
in the areas they regulate. Also European Notified Bodies also periodically
update their expectations, and for suppliers this happened with the publication
of a guidance document by the Notified Body Operations Group (NBOG).

This seminar will go into the details of the NBOG
supplier guidance document and a GHTF (Global Harmonization Task Force) guidance
that describes the current FDA expectation on supplier management.

One of the major things introduced in these guidance
document, is the concept of Risk, and the use of identified risks as part of
the evaluation and monitoring of suppliers.

This seminar will review requirements and expectation
of the FDA and European Notified Bodies for supplier management, and then how
to incorporate these into your own supplier management process.

Covered in the Session:

  • Understand FDA QSR and
    ISO 13485 requirements for supplier management
  • Creating a Risk-based
    Multi-tier supplier classification system
  • Understand when
    suppliers have to register and list with the FDA
  • Defining and using
    supplier Metrics
  • Explain the link between
    design control and purchasing data
  • Develop an risk-based
    supplier management process
    • Incorporating supplier
      regulatory and safety risk
    • Incorporating supplier
      business risk
  • Create supplier
    measurement and monitoring systems
  • Understand the how to
    develop and implement supplier controls
  • Create a risk based
    Value-added system for supplier audits
  • How to prepare yourself
    and your contract manufacturer for unannounced audits from your Notified
  • Creating acceptance
    criteria and understand how that fits into your supplier control process

Who will

  • Quality
  • Quality
  • Audit
  • Supplier
  • Internal
    quality auditors
  • Supplier
  • Quality
  • Quality
  • Regulatory
    Compliance Managers   


Day 1

Lecture 1:


Lecture 2:

Fundamentals Regulatory Requirements

  • FDA
  • ISO
    13485 requirements
  • Understanding
    the role of the Global Harmonization Task Force Guideline
  • Understanding
    NBOC Guideline and why it should be used

Lecture 3:

Planning the Supplier Management

  • Supplier
  • Supplier
    QA agreements what are they and why are then

Day 2

Lecture 1:

Planning Supplier Selection

Lecture 2:

Potential Suppliers

Lecture 3:

Supplier Selection

Lecture 4:

Implementing Supplier Controls

Lecture 5:

Measuring, and Evaluation

  • Periodic
  • Re-evaluations

Lecture 6:

Supplier Audits - where do they add

  • Planning
    your supplier audit schedule
  • How
    Notified Body unannounced audits affect your contract manufacturer
  • What
    you should do to prepare yourself and your contract manufacturer for
    unannounced Notified body audits

Lecture 7:

Feedback and Communication

  • Supplier
    meetings: Partnering with Key suppliers
  • Supplier
    Corrective Actions

Lecture 8:

Evaluating your current program to
see how it measures up to regulatory Expectations


Betty Lane,

Founder and President, Be Quality Associates, LLC

Betty Lane has over 30 years' experience in Medical Device quality
assurance and regulatory affairs. She is the founder and President of Be
Quality Associates, LLC, a consulting company helping small and medium sized
medical device and diagnostic companies implement and improve their quality
systems. Her work enables companies to manage their business in compliance with
FDA and ISO 13485 requirements, as well for quality system requirements for
other geographic area such as Europe and Canada. Her background in digital
systems engineering enables her to facilitate quality system processes for
design controls and software validation. Her areas of expertise include
training, auditing, supplier management, document and records management,
design controls, and software validation.

training experience includes over 25 years of training on all aspects of ISO
13485, the ISO standard for Medical Device - Quality Management Systems -
System Requirements for regulatory purposes, and FDA Quality System Regulation
- Medical Devices; Good Manufacturing Practice (cGMP), in companies where she
worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ
sections. She has taught courses in medical device and biotechnology quality
and regulatory affairs as an Adjunct at Northeastern University, Boston, MA.
Betty is active in her local section of the American Society for Quality and is
also a member of the Association for the Advancement of Medical Instrumentation
(AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in
engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from
Northeastern University.

Location: Zurich, SwitzerlandDate:
April 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Hilton Zurich Airport

Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland




$1,695.00 (Seminar Fee for One Delegate)


Until February 28, Early Bird Price: $1,695.00
from March 01 to April 08, Regular Price: $1,895.00


Register for 5 attendees Price: $5,085.00 $8,475.00
You Save: $3,390.00 (40%)*



NetZealous DBA as GlobalCompliancePanel


Phone: 1-800-447-9407

Fax: 302-288-6884



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