Calendar of Events
Highlights
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MARCH 23 - MARCH 27, 2009 DISNEYLAND HOTEL ANAHEIM, CALIFORNIA
MSC Offices: 1280 Bison Avenue, Suite B9-530 Newport Beach, CA 92660
Phone
WORKSHOP:
A Quality Calibration Program for ISO & QSR Programs
Jay L.
Bucher
Bucherview
Metrology Services, LLC
(Half-Day)
If a business (biotech, pharmaceutical, chemical, or any life science company) expects to be a player in its market segment, their product(s) must have the quality demanded by their customers. This can only be accomplished with test instruments that produce repeatable, accurate and traceable measurements and/or outputs. In the 21st Century, most industries have compliance standards (i.e. ISO 9000 or ISO 13485) or regulator requirements (QSR, cGMP, etc. for the FDA) that view calibration of test equipment as a top priority. It is common knowledge that the calibration function is one of the top three areas written up for non-compliance to ISO standards and QSR regulations.
It isn’t enough to just calibrate a piece of test equipment anymore. Calibration procedures must be written and followed. Records for each and every calibration must be completed, signed, saved and archived. A written process must be in place for items that are found to be out-of-tolerance – and this is only the tip of the quality calibration program iceberg. Traceability, calibration standards, uncertainty budgets, calibration intervals, labels and the environment must also be documented. We will also review calibration management software, scheduling practices, training and continuous process improvements.
This tutorial will cover the calibration requirements needed to meet and exceed the standards and regulations most industries must comply with to be productive in today’s fast paced, fiscally savvy environment. The lessons learned from developing, implementing and managing a ‘Best in Class’ calibration program will be shared with the attendees. Examples of calibration procedures, records (electronic and hard copy) and interval analysis will help demonstrate how easy it is to have a quality calibration program at your own company, while saving time and money by not having to send all your test equipment out for calibration.
WORKSHOP:
Paperless Records – Going, Going, Gone!
Jay L.
Bucher
Bucherview Metrology Services, LLC
(Half-Day)
I’ve written numerous articles and given many presentations on why a
metrology or calibration department should go paperless with your
calibration records. After the presentations, I always ask why the
attendees have not tried, or started a paperless program. The most
prevalent answer is…”We don’t want to get written up during an
audit.”
That sounds about as logical as not driving a car because you’re
afraid of getting a ticket. If everyone follows the law concerning
your speed, parking, drinking and driving, and not causing
accidents; then you don’t have to worry about getting a ticket. The
same can be said about going paperless. The FDA’s quality system
regulation (QSR) and ISO standards have their guidelines and
regulations. When they are followed, there usually are no problems.
After attending this tutorial, the reasons for not going paperless
will have been greatly reduced or eliminated.
This tutorial will cover how to use MS Word and Adobe Acrobat
Professional in designing and creating their own electronic forms.
Attendees will get Lessons Learned about formatting, field
placement, editing finished forms and protecting both the form that
you use and the data recorded from modification and tampering. All
journeys start with the first step…isn’t it about time?
- Metrology’s Impact on Global Trade
San Antonio Convention Center, San Antonio, TX
July 26 - July 30, 2009
- NCSLI Madison Wisconsin Section Meeting
October 2008
Dates, Place and Agenda TBA