Upstate New York Section (1122)

NCSLI Division VP
Marcus McNeely
P.O. Box 830
State College, PA 16804
814-234-2417
mbncneely@coolblue.com




NCSLI Upcoming Meeting and Events


This meeting has been cancelled.
The reschedule date is to be announced at a later time.

Upstate New York Section Meeting
Wednesday, May 15, 2013


Please Join Us!



Meeting Time:
8:00 AM - 5:00 PM

Cost to attend:
No charge

Meeting Host and Directions

Meeting Host:
Transcat

Meeting Location:
Transcat
35 Vantage Point Drive
Rochester, NY 14624
585-352-9720

Meeting Directions  (Click on for directions)


Meeting Overview:
The purpose of this event is to create awareness and provide training on a number of measurement science topics broken into modules, with various experts teaching principles directed toward specific measurement and documentation disciplines.

Meeting Speakers:
Speakers' Name: Phil Mistretta, Transcat
Topic:Producing Valid Results (Risk mitigation and Measurement Assurance)

Abstract: Quality measurements are not produced by accident. They are not the result of a single action, occurrence, or event. They are a collection of activities that are planned, interrelated and cohesive; they should be considered alongside the development of processes and not an afterthought. Measurement activities are inextricably linked to product quality and manufacturing systems. These activities collectively are referred to as Measurement Assurance. Measurement assurance is good for product quality and good for business, and can even be legislated.  “Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.”(21 CFR 820.72).

Speakers' Name: Howard Zion, Transcat
Topic: Calibration’s Role in the Manufacturing Jigsaw Puzzle
Abstract:
This seminar discusses how calibration fits into manufacturing or the jigsaw puzzle we call manufacturing. Whether relying on an external commercial calibration supplier or an internal calibration laboratory, there are a number of disconnects that can inadvertently cause problems for the end product and that can be costly!

Topic: Suitability of Instruments (Measurement Assurance and Risk Mitigation)

Abstract: “Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.”(21 CFR 820.72). While this quote is intended for Medical Device manufacturers, the concept behind it gets to the root of good manufacturing practices for any industry with an interest in minimizing rework, scrap, recall, and/or safety problems in order to maximize profits.  And everyone likes more cash . . . well, except her (as Jimmy Fallon states in the Capital One commercial).  The problem is some companies don’t make the connection that the instruments that are selected and used to quantify decisions about a process or about their product may be driving one or more of the root causes of these profit pilfering penalties.

Speakers' Name: Marcus McNeely, Blue Mountain Quality Resources
Topic: Pharmaceutical / Bio Tech / Medical Device Metrology Documentation Best Practices - An Industry Overview
Abstract:
This session overviews industry current practices in the creation of effective Healthcare Metrology Calibration Master Plans (Quality Manuals) and their Sub-Documentation procedures. Additionally, strategic Equipment Lifecycle planning and documentation is considered.
 
Meeting Schedule:

8:00 – 8:15 Registration and Introductions

8:15 – 8:45 Introduction to NCSLI and BOD Update

8:45 – 9:45 Producing Valid Measurement Results

9:45 – 10:45 Calibration’s Role in the Manufacturing Jigsaw Puzzle

10:45 – 11:00 Break

11:00 – 12:00 Suitability of Instruments

12:00 – 1:00 Lunch

1:00 – 3:45  Pharmaceutical / Bio Tech / Medical Device Metrology Documentation Best Practices - An Industry Overview

3:45 – 4:00 Break 

4:00 – 5:00 Laboratory Tour

5:00 - Wrap Up