This online course provides a look at new information in the Water and Steam Systems (Second Edition) Baseline Guide. It will touch on the high level concepts associated with regulatory background, water options and system planning; Pretreatment and final treatment options; storage and distribution, microbial considerations, laboratory water; pharmaceutical steam; and rouge and stainless steel. This session will touch on high level concepts associated with these objectives:
- Regulatory Background, Water Options and System Planning
- Pretreatment and Final Treatment Options
- Storage and Distribution
- Microbial Considerations
- Laboratory Water
- Pharmaceutical Steam
- Rouge and Stainless Steel
Attendance suggested for:
- Pharmaceutical professionals who are new to water treatment systems or those with significant engineering expertise from another industry who need to learn about pharmaceutical water treatment systems.
- Those with significant industry experience in other capacities who now have water generation system engineering and/or maintenance responsibilities and want to gain a fundamental understanding of the requirements for designing, building, operating testing, and maintaining these systems.
- Water treatment systems quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water generation systems.
- Those with significant pharmaceutical water experience who want understand current industry trends and ISPE consensus views.
Andrew Collentro is Technical Director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE Training Faculty, and has taught courses for PDA and other industry organizations. He is also a Chapter Leader for the ISPE Baseline® Guide for Water and Steam Systems and past Chair of the ISPE Critical Utilities Community of Practice (CoP).
Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide. He has been part of the Guide Presentation Team on several occasions. He was involved in face-to-face meetings with FDA to help resolve many of the Guide principles. Zoccolante is a member of the ISPE Critical Utilities Community of Practice Steering Committee. He has worked on the development of the ISPE “Good Practice Guide - - Commissioning and Qualification of Pharmaceutical Water and Steam Systems”. He was selected to deliver the first public presentation of the Guide. Zoccolante developed the four-day ISPE Pharmaceutical Water course and has presented the course to hundreds of pharmaceutical industry personnel including FDA personnel. Zoccolante is a frequent lecturer for many pharmaceutical groups and has chaired many courses. He has presented for ISPE, Interphex, American Institute of Chemical Engineers, American Society of Mechanical Engineers, Institute for International Research, Center for Professional Advancement, PDA, Pharmtec, Barnett International and many others. He has conducted several in-house courses on pharmaceutical water production and regulatory requirements for pharmaceutical companies. Zoccolante has authored and co-authored many papers on pharmaceutical water production and system operation and maintenance. He holds patents for pharmaceutical water processes. He has previous experience as manager of engineering and manager of application engineering. He holds a B.S. degree in Mechanical Engineering from Northeastern University.