The importance of calibration (Date change: November 12)

Calibration photo

Instrument calibration

Calibration is one of the Quality Systems that is of high importance to the overall Quality Management System that manufacturers (like pharmaceutical) must employ in order to be compliant with regulatory authorities.  The presenters will  address calibration system cGMP requirements, practical and effective facilities implementation, and include examples of tools for compliant and lean systems.  The focus of the discussions will be loop calibrations based on the process evaluations, and calibration systems as a part of the maintenance reliability program.  Examples of computerized and paperless calibration will be presented as possible tools within calibration programs.  Understanding of the processes and quality requirements shall be shown to be the centerpiece of any calibration system.

Speakers:

Yefim Gudesblat, PE
Gudesblat is presently working as a consultant engineer in the industry. He supports clients in varieties of electrical, instrumentation and automation project engineering developments. In 1971, Gudesblat completed his studies in physics and electrical technology in Odessa, Ukraine (Formally USSR). He is a registered Professional Engineer in Pennsylvania, New Jersey and North Carolina. Gudesblat has over 30 years of experience in the pharmaceutical industry and published several articles in the leading United State technical journals, included Pharmaceutical Engineering. He was employed and consulted Wyeth, Johnson & Johnson, Merck, Baxter and other biopharma companies. Currently Gudesblat established Exact Performance, LLC and could be reached by e-mail: ygudesblat@exactperformancellc.com and phone: 610.701.1976, fax 484.879.2204

Bernard Williams, M.E., Director, Sales Engineering & Consulting, Prime Technologies, Inc.
Williams is an executive with more than 35 years engineering and management experience with leading edge technology companies. He has worked in such diverse fields as Power Generation, Holography, Analytical Chemical Systems and Process Automation. For the last fifteen years he has worked with Prime Technologies, Inc. as The Senior Technology Consultant and contributor to the development of their ProCalV5, Compliant Computerized Calibration Management Solution.

DATE & TIME: Wednesday, November 12, 2014: Open 5:15 PM – Light meal at 5:30 PM ($12.50); Meeting starts at 6:30 PM – Speaker’s presentation 6:45 PM to 7:45 PM – Vendor displays & socialize before & after talk.

LOCATION: Ives Equipment Corp. 601 Croton Road, King of Prussia, PA 19406

COST: $12.50, payable online or at the door via cash or credit card. Please contact Sue DiPaolo by Monday, November 10 or by E-mail: sue.dipaolo@jacobs.com, or by phone: 610-238-1067.

 

ISPE: October Education Session – Part One of a Two Part Series

OCTOBER 22, 2014 (Wednesday)

Calibration in the Pharmaceutical Environment

114The first education workshop in our 2014/2015 series will discuss Calibration Requirements in the Pharmaceutical Industry.

The importance of calibration can not be overstated. Calibration is one of the Quality Systems that is of high importance to the overall Quality Management System that pharmaceutical manufacturers must employ in order to be compliant with regulatory authorities.

The presenters will address calibration system cGMP requirements, practical and effective facilities implementation, and include examples of tools for compliant and lean systems.

The focus of the discussions will be loop calibrations based on the process evaluations, and calibration systems as a part of the maintenance reliability program.

Examples of computerized and paperless calibration will be presented as possible tools within calibration programs.

Understanding of the processes and quality requirements shall be shown to be the centerpiece of any calibration system.

Who Should Attend?

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Wagner and 3D printers

Dan Wagner discusses capabilities of 3D printers during tour following presentations. Inset shows process model created by a 3D printer

Dan Wagner began the presentation by profiling PRISM Engineering. He said it is a leading provider of 3D CAD and CAM solutions with about 40 employees–technicians, engineers, machinists and trainers. The firm offers and trains on SolidWorks 3D computer aided design software, Mastercam design and computer aided manufacturing software, and Stratasys 3D printers. The firm also provides CAD/CAM services. Continue reading

Scholarship applications are being accepted by ISA Process Measurement and Control Division (PMCD)

Applications Due by 30 November

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Applicants must be nominated by PMCD members and be enrolled in an undergraduate or graduate program related to process measurement and control.

The application deadline is 30 November 2014. ISA student members who contribute to the Society early in their careers are apt to become members for the long term. Continue reading