Monday, February 2, 2015

Harmonization of C& Q and CSV initiatives!

Forthcoming Technical Talk from the ISA Ireland Section is to be held at Rochestown Park Hotel in Cork on Wednesday, 18 February 2015 @ 19.00hrs sharp.

The Speaker
Jorge L. Rodriguez is the Founder, President and CEO of PACIV, a control system engineering firm. PACIV has offices in Puerto Rico, United States and Ireland. PACIV provides operational efficiencies through the automation of manufacturing processes utilizing instrumentation and control systems. PACIV clients include the largest Biotechnology, Pharmaceutical, and Medical Device companies in the world as well as other multinational clients in related industries. PACIV has over 120 associates world-wide and has revenues, in the past 16 years, of over $135 million.

Prior to founding PACIV, he worked for over 8 years as a control system engineer in various positions within Westinghouse Electric, Eli Lilly & Co. and J&J Janssen.

“Harmonization of C&Q and CSV Initiatives” by Jorge L. Rodríguez – President & CEO – PACIV

In many instances there is significant overlap between the computerized system validation and the commissioning and qualification activities specially for computerized control systems utilized in the manufacturing, facilities and/or utility processes (e.g. PLC’s, SCADA, DCS). As such, these efforts may be combined under one effort, to ensure proper synchronization and preclude duplication of effort. As a result, a single validation/qualification effort may be performed to produce the required deliverables to achieve compliance while harmonizing work being done even when using different teams. Moreover, the commissioning effort can reduce significantly not only the qualification effort but also the CSV effort, if performed appropriately.

In today’s competitive environment, clear and concise policies and procedures that promote such harmonization effort, regardless of the type of regulated manufacturing process and automation platform, will offer significant value by reducing the cost as well as the time it will take to complete such projects while still meeting the required level of compliance.

• Pre-registration on the ISA Ireland website would be helpful (not necessary to attend) as it would give us an indication of how many to expect on the night. On the section website under “Upcoming Events” for Wednesday 18 February click on “more info”, then follow the next prompt and click on “info” for ISA Tech Talk and you will notice a registration template at the bottom of the page.

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