Clinic #1 – Problem Solving: Don’t Just Follow the Herd – Observe the Landscape First! – 0.5 RU’s
Clinic #2 – ISO 11607-1/-2 Packaging for Terminally Sterilized Medical Devices – 0.5 RU’s
Dinner Presentation: Effective Gemba Walks for Servant Leaders – 0.5 RU’s

 

When : Tuesday, January 8, 2019 5:15 PM  –  9:00 PM
Where :
Wyndham Hotel Irvine 17941 Von Karman Ave. Irvine, California 92614 USA

Register here
View event summary here

 

Clinic #1: Problem Solving: Don’t Just Follow the Herd – Observe the Landscape First!

Case study in fixing the quality problem of a Life-saving angioplasty catheter

Summary:

– Don’t “shoot-from-the hip!” You might kill someone innocent!
– Decide where the problem is not – no need to look for solution there
– Find the problem
– Solve it for good!
– Applies everywhere, not just in medical products

Clinic presented by: Jack Dhuwalla

 

Clinic #2: ISO 11607-1/-2 Packaging for Terminally Sterilized Medical Devices

The ISO 11607 standards are the first packaging qualification standards developed with emphasize on terminally sterilized medical devices.  The FDA worked with the ISO committee that developed the standards for harmonization.  The standards define the product and packaging, that maintains sterility, as equal for successfully and safe use.  The initial packaging standard was developed for hospitals and was expanded to include medical device manufacturers.  The FDA also would like sterile combination devices to the mix for requirements. Now – the standards are being revised to include more requirements not included in most requirements.

By attending this clinic presentation, you will:
– Learn the basic requirements for the two ISO 11607 standards
– Understand the ISO 11607 standards require information necessary beyond normal package engineering work to claim compliance
– Learn about the new requirements coming to the ISO 11607 standards, expected in 2019

Clinic presented by: Jan Gates

Dinner Presentation: Effective Gemba Walks for Servant Leaders

In today’s competitive environment, prompt data flow and decision making are crucial to keep morale high and the company/department on the right track.

By attending this clinic presentation, you will get…

– Differentiate between right/wrong ways of Gemba walking
– Connecting the dots : Hoshin Kanri  Daily Gemba Walks  Kaizen
– Understanding what servant and failed leadership look like and how it affects site performance
– Perspective of lean transformation in highly regulated industries (biotech, medical devices,aerospace)

Dinner speaker: Franklin Davis