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Metrics: The Balance of Performance & Compliance
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Regis Technologies invites you for a seminar on "Metrics: the Balance of Performance & Compliance" delivered by guest speaker Jason J. Orloff, a chemical engineer and international consultant with over 15 years in the industry. Read the abstract below for more details. A light breakfast will be served. Join us for coffee and chemistry on Thursday, November 12th, 8-9:30AM. Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.

11/12/2015
When: Thursday, November 12, 2015
8 - 9:30 a.m.
Where: 8210 Austin Avenue
Morton Grove, Illinois  60053
United States
Contact: 847-583-7675

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Regis Technologies invites you for a seminar on "Metrics: the Balance of Performance & Compliance" delivered by guest speaker Jason J. Orloff, a chemical engineer and international consultant with over 15 years in the industry.

 

Read the abstract below for more details.

 

A light breakfast will be served.

 

Metrics: the Balance of Performance & Compliance

 

Jason J. Orloff

 

Wave after wave of quality initiatives have come from other industries and failed to take root. This could be because Pharmaceutical Quality Culture is unlike any other industrial culture. Certainly our risk profile of medium volumes, high costs, and high risks are radically different from the high volumes, low risk, low costs of cell phones, cars, and computer chips. Pharmaceutical Quality Culture is a dynamic, self-correcting system that represents both compliance and performance. A maximally efficient, agile, flexible, pharmaceutical manufacturing sector could be achieved with minimal regulatory oversight by formalizing the systems of performance and ensuring that the balance of compliance and performance is maintained. Process capability measured in %OOS is one such metric where compliance with specifications is weighed against the performance of the process. But where does process capability itself belong: As a compliance reportable? Or as a self-audit of performance done by manufacturing for senior management to prioritize continuous improvement?

 

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