Engineering and the Quality Unit: Why Can’t We Get Along?
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Speaker : NISSAN COHEN
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When : Tuesday, April 22, 2025
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Time : 01 : 00 PM EST
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Dr. Nissan Cohen
A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology.
Co-Chairman, Contributing author and Chapter Leader of International Society for Pharmaceutical Engineering’s (ISPE) “Baseline Guide for Pharmaceutical Water and Steam Systems”. Revisions 1, 2, and 3
Co-chairman and Coordinating Author of the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.
Contributing author to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide on Ozone.
Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine.
Education: University of Wisconsin and Ruppin Institute – in Agriculture and Genetics. Masters and Ph.D studies in agricultural water, Hebrew University, Agriculture Faculty. Developed and Patented an Automated Flushing System for Drip Irrigation. Developed, patented, and built the first Computerization of Drip Irrigation Systems with Remote Wireless Control and Operation.
Member of International Standards Committees: ASTM E-55, IEST (WG 14644 Contamination Control – authors of ISO-14644), ASTM D-19.03, ISPE (International Society for Pharmaceutical Engineering) Steering Committee member for Communities of Practice Standards: Critical Utilities
Often different departments in biopharmaceutical companies have varying interpretations of their responsibility and authority. These interpretations can devolve into conflicts between different departments. Although the overall goals and targets of the production and manufacturing operation are understood, the individual interpretation of how to attain those goals and targets may be quite different.
The engineering department’s mantra is “How do I meet specification?” This may include the specification of compendial mandates, URS specifications, and the introduction of new technology to measure or assess these compendial and URS mandates.
Quality’s mantra is “How do I ensure Quality Assurance and/or Quality Control?” Quality’s mantra is always quality control and quality assurance to ensure product deviations are not present and the product meets all quality attributes.
Unfortunately, these departments may have conflicting procedures and metrics which can cause friction between the entities.
Areas Covered
- Assumptions of common goals
- Mandates of Engineering
- Mandates of the Quality Unit
- Responsibility and authority over specific operations
- Turf oriented conflicts
- Cooperation and resolution
Who Should Attend
Engineering and Quality personnel
Why Should You Attend
This tongue-in-cheek presentation is a simple analysis of the Engineering and Quality units’ functions and goals. These functions and goals should be universally accepted by both entities. However, there are often conflicts that arise due to turf orientation, responsibility identification, and interpretation of what is needed for regulatory and internal compliance.
Understanding the interpretations and goals of each unit’s operation is imperative for a cohesive manufacturing and production environment.
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$199.00
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