NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc Mr. Cohen has over 40 years of experience in high technology industries of pharmaceuticals, biotechnology, agriculture, mission-critical technology, medical devices, genetics, and semiconductors. He has held positions in senior management, sales management, account management, strategic business development, marketing management, product and applications development, product management, regulatory compliance, and corporate business development.

Mr. Cohen is an accomplished writer of over 40 technical articles, published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology. He is a co-chairman, contributing author, and chapter leader of the “Baseline Guide for Pharmaceutical Water and Steam Systems (an ISPE publication), co- chairman and chief author of “New Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems” Good Practice Guide”, an ISPE publication, Co-chair and Contributing Author of the Good Practice Guide for Ozone, ISPE Publication. Co-chair for the ISPE Good Practice Guide for Process Gases, and contributing author and chief reviewer for ISPE Good Practice Guide for Membrane-based WFI Systems. 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, and Former member of the Technical Advisory Board of A2C2 magazine. KEY COMPETENCIES

Pharmaceutical Water Systems Business Development Pharmaceutical Engineering cGMP Environmental Monitoring Commissioning and Qualification 21 CFR Part 11 Cleanroom Classification and Testing Process Analytical Technology (PAT) Process Instrumentation Microbial Mitigation USP Water Mandates and Compliance Gap Analysis SOP Documentation Regulatory Compliance EXPERIENCE

Biopharmaceutical

Water Doc

Lafayette, CO

Owner

Duration of Assignment: 20 Years

• Initiated business development for high-tech start-ups in advanced oxidation systems, ozone generation and monitoring, UV and photocatalysis, separation technologies using centrifugation, sensors and instrumentation technologies, mission-critical data acquisition systems, and medical devices.

• On-site consulting and diagnostics for Purified Water, WFI, Steam, and Pure Steam.

• Member of IEST (Institute of Environmental Sciences and Technology) WG14644

(Contamination Control), authors of ISO-14644 and precursor FED-209E. Expertise in environmental monitoring for controlled and cleanroom manufacturing areas for all ISO and European classifications including, aseptic, particulates, viable microbials, air pressure, air room changes, flow rates, humidity, HEPA, ULPA, and MERV filtration applications, plenum returns, hard and soft wall, raised floors, interventions etc.

NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc

• Expertise and Consulting in FDA 21st Century Initiatives, 21 CFR Part 11, International harmonization ICH 7a, 7b, 8, 9, 10, 11, 12, 13; EMA, USP, JP, Ph. Eur., China P, Process Analytical Technology (PAT), Process automation, continuous validation, GxP, cGMP, Commissioning and Qualification, IQ, OQ, and PQ, QA/QC data acquisition, and critical process monitoring.

• Noted worldwide Subject Matter Expert in high purity, ultrapure, recycle, reclaim, and drinking water systems. Emphasis in pharmaceutical, biotechnology, hemodialysis, and semiconductor industries.

• Noted lecturer in USP Purified and WFI water systems, Statistical Process Control and Exponentially Weighted Process Statistics, Process Analytical Technology, Sustainability, Carbon Zero attainment, Zero Liquid Discharge, and Regulatory compliance including Annex 1.

Rohrback Cosasco

Systems

Santa Fe Springs, CA

Business Development Manager

Duration of Assignment: 5 Years

• Developed, managed, and introduced a new online product for corrosion monitoring, commonly known as “rouge monitoring” in the Pharmaceutical and Biotechnology markets. First device ever devised to measure online rouge in pharmaceutical water and steam systems

• Produced, wrote, and authored all documentation including IQ/OQ, PAT, calibration verification and compliance documents to 21CFR11

• Produced, wrote and presented papers and presentations on Rouge, Rouge Monitoring with economic value proposals, and case studies.

• Developed, hired, and managed a worldwide sales and marketing organization in all major pharmaceutical producing countries using remote offices, local sales representatives, and industry alliances.

• Helped institute and integrate new technology into regulatory forums, industry leading associations, and standards committees.

• Aggregate sales of over $500,000 in three years after introduction, testing, one- year beta site testing, and data publishing

DataTrax Systems

Lafayette, CO

International and Eastern Region Sales Manager, Powerware Division, Invensys Duration of Assignment: 5 Years

• Mission-critical software, monitoring, data acquisition of data centers with remote, local, regional monitoring in real-time.

• Developed international sales channels, in UK, Europe, Mideast, Asia, Southeast Asia, Africa, Australia, Oceania, South America, and Central America. Sales increased from less than $50,000 to over $1.5 million annual revenue in less than 20 months.

• Trained, developed, maintained, and hired sales channels around the world for vertical applications in mission-critical monitoring for banking, financial institutions, telecommunications companies, Internet providers, and data centers.

NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc

• Formulated strategic marketing, product, and applications plans with disparate and complimentary corporate partners within a diversified conglomerate.

• With targeted sales and major account management of Fortune 500 companies, helped increase revenues of DataTrax from <$5,000,000 to $15,000,000 annual revenue in 18 months. Typical accounts: JP Morgan Chase, MBNA, Level 3, iAsiaworks, US Department of State, US Department of Defense, HSBC, Qwest, SBC, AT&T, IBM, Deutsche Bank, US AID, Intel, Motorola

• Responsible for government and commercial sales, applications development, and contract negotiations with U.S. and international entities. Anatel Corporation

Boulder, CO

Vice-President of Sales; Manager TOC Sales; Regional Sales Manager Duration of Assignment: 11 Years

• Implemented and conceived the strategic plans for applications, market penetration, market segmentation, and governmental regulation development for the pharmaceutical industry developing a yearly $150 million market in less than 5 years.

• Fostered the market development and product development for applications in the lab water market, reuse and reclaim applications in the semiconductor industry, and clean-in-place technology for the pharmaceutical industry yielding a niche annual market of $15 million.

• Managed and developed a 35% annual sales growth rate over five years.

• Developed a successful, highly integrated, and knowledgeable professional sales force with strategic selling and conceptual selling methodologies comprised of direct employees, regional managers, manufacturer’s representatives, agents, and master distributors world-wide.

• Administrative tasks included company sales forecasts, annual budget formulation for sales, marketing, and sales administration departments, formulation of commission and compensation plans, territory selection and adjudication, foreign agents and representation selection, and representation on regulatory, industry committees, and professional societies. HISTORY & TRAINING

History: • Advanced Masters and Ph. D studies in Agricultural Water Systems, Hebrew University (Israel)

• BS, Agriculture and Genetics, Ruppin Institute (Israel) Affiliations: • ISPE, Member

• ISPE, Steering Committee Member, ISPE Communities of Practice: Subject Matter Expert for Critical Utilities, Commissioning and Qualification, Process Analytical Technology, Sterile Product Processing, HVAC, Sustainability.

• International Standards Committees: ASTM E-55, IEST (WG 14644 Contamination Control), ASTM D-19.03

Awards: • Four times nominated and one-time winner of Pharmaceutical Engineering’s

“Article of the Year”

NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc

• Advanced Graduate Studies in Agricultural Water Systems, Hebrew University, Israel. Patented work in “Automated Flushing Systems for Drip Irrigation” (1975).

• Advanced Graduate Studies in Agricultural Water Systems, Hebrew University, Israel. Patented work in “Integrated Computerization of Agricultural Water Systems with Radio Frequency Operation” (1979)

Publications: Not all

Inclusive

• “Introduction to Steam Quality and Testing”, Pharmaceutical Engineering, July/August 2022

• Rapid Microbial Monitoring: Adoption, Applications, and Regulatory Guidance, Pharmaceutical Engineering, March/April 2018, volume 38 number 2

• Breaking the Paradigm: New Technologies, Ideas, and Adaptations for Biotechnology Facilities, Pharmaceutical Engineering, September/October 2016, Volume 36 number 5

• “Performance and Validation of Ozone Generation for Pharmaceutical Water Systems”, Pharmaceutical Engineering, July/August 2017 volume 37 number 4

• Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination, “Pharmaceutical Engineering”, July/August 2014 Volume 34, Number 4

• “How to Determine Rouge Limits to Initiate Derouging and Passivation”, Technical Brief KB-0029, January 2014, International Society for Pharmaceutical Engineering

• “The Efficacy of Ozonated Water in Biofilm Control in USP Purified Water Circulation and Storage”, Pharmaceutical Engineering, November/December issue 2013

• “Understanding Dissolved Ozone and its Use in Pharmaceutical Water Systems”, published May 2013, Technical Brief, KB-0027, International Society for Pharmaceutical Engineering.

• “Economic and Efficacy Comparison between Ozone and Hot Water Sanitization”, ISPE Tampa Conference, February 2013

• “Calculating the Cost of USP Purified or WFI water by the Gallon, Liter, or Metric Ton”, Published in ISPEak, July 2012

• “Source water and its Impact on Pharmaceutical Water”, published in ISPEak, February, 2012 publication of the International Society for Pharmaceutical Engineering

• “On-line Rouge Monitoring: A Science-Based Technology to Determine Rouge Rates”, Pharmaceutical Engineering, November/December 2011, Volume 31, Number 6

• “Dissolved Ozone in Pharmaceutical Water Systems …Why Use and Measure Dissolved Ozone”, Published in PharmaceuticalOnline June 24, 2010

• “How Smart is Your TOC Analyzer?” Pharmaceutical Engineering, January/February 2008

NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc

• “The Use of Exponentially Weighted Process Statistics (EWPS) and Statistical Process Control (SPC) in High Frequency Data Acquisition of Pharmaceutical Waters Systems Instrumentation”, Pharmaceutical Engineering, March/April 2007

• “Automated Release of Water Using On-line TOC Analysis and FDA Risk-based cGMP, Inspection and PAT Principles”, Pharmaceutical Engineering, January/February 2005

• “An Introduction to Process Analytical Technology”, Pharmaceutical Engineering, January/February 2004

• “Power: The Unregulated Utility in the Pharmaceutical Environment”, A2C2 Magazine, May 2004

• “Monitoring Mission-Critical 24/7 IT Data Centers in a Pharmaceutical Facility”, Pharmaceutical Engineering, January/February 2002

• “Validation of a Water System for the 21st Century”, Pharmaceutical Engineering, July/August 1999

• “Pretreatment Strategies for TOC Reduction in WFI and USP Purified Water”, Pharmaceutical Technology, June 1995

• “Characteristics of a UF Recirculating Deionized Water Systems Used in the Manufacture of Biomedical Devices”, Ultrapure Water, November 1993

• “Current and Future Trends in Point-of-Use Monitoring”, Ultrapure Water, October 1993

Presentations: Not

all inclusive

• Process Analytical Technology (PAT) versus Traditional Validation, (Tecnología analítica de procesos (PAT) frente a validación tradicional), Symposio de Validacion, National College of Chemicals, Pharmaceuticals, and Biologics of Mexico, Mexico City, Mexico June 8, 2023

• Annex 1 Chapter 6 and its Comparison to Compendial Mandates for Water and Steam. What does it all imply to the industry? ISPE European Water conference October 19, 2022

• “Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems", ISPE India October 7, 2022.

• “Introduction to Steam Quality and Testing”, Pharmaceutical Engineering, July/August 2022

• “Production of WFI Water Without Distillation - New Changes in the European Pharmacopeia”, March 16, 2022, ISPE Singapore.

• “Changed Regulations for Pharma Water Systems: What it means for the Pharma Industry”, ISPE India, December 2, 2021

• “Microbial Control for Pharmaceutical Pretreatment, Purified Water (PW), and Water for Injection

• (WFI) Water Systems”, KENX, November 18, 2021

NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc

• "Microbial Issues and its Mitigation in Pharmaceutical Waters", ISPE Malaysia, March 26, 2021

• “Key aspects of Risk Management in the Qualification and Validation of Water Systems for Pharmaceutical Use”, IX Symposium of the National College of Chemicals, Pharmaceuticals, and Biologics of Mexico, March 22, 2021

• “Validation of a Water Quality System” – (based on Baseline Guide Volume 5), ISPE India, webinar series, January 8, 2021

• “Emerging Technologies in Pharmaceutical Water Systems, Membrane based WFI and Ozone Sanitized WFI Water Loops”, ISPE Boston, October 6, 2020

• “Pretreatment Designs for Pharmaceutical Water Systems in Monsoon Affected Countries”, ISPE India, webinar series, April 24, 2020

• “Process Analytical Technology vs. Traditional Validation”, ISPE South Asia Conference September 2019, Bangalore, India.

• Overview of the Baseline Guide for Water and Steam Systems Version 3, ISPE Webinar Series, November 2019

• “Annex 1 - what are the implications of its adoption to Critical Utilities”, ISPE Nordic Water Conference, September 2018, Stockholm, Sweden

• The attainment of Zero Liquid Discharge from Biopharmaceutical Manufacturing Facilities, ISPE Annual Meeting, San Diego 2017

• Zero Liquid Discharge: How to Reclaim, Recycle, Reuse, and Reduce Pharmaceutical Waters, ISPE Annual Meeting, San Diego 2017

• Myths and Realities: The Legacy of Obsolete SOPs and Specification in Modern Pharmaceutical Water Systems”, Ultrapure Water Pharmaceutical Conference, June 2015

• Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems, “ISPE Los Angeles Chapter Symposium”, May 2015

• “The Efficacy of Ozone and Chemical Sanitization for Microbial Control”, presentation, Ultrapure Water Pharmaceutical Conference, June 2013

• “Paradigm Shift in Pharmaceutical Manufacturing Business Model”, ISPE Manufacturing Conference, Tampa 2009

• “Validation of a new piece of process equipment – PAT vs. traditional validation”, Presentation ISPE Winter Meeting, February 2007, Tampa FL

• “System Suitability is Not Calibration”, presented Ultrapure Water Conference, May 1998

• “The Computerization of Water Systems including On-line Instrumentation, Integration, Electronically Generated Documentation, SPC, and High Frequency Data”, ISPE Winter Meeting, Tampa 2006

• “Validation of a Water System for the 21st Century”, Presentation, International Society for Pharmaceutical Engineering (ISPE), October 2007 NISSAN COHEN

Owner and Principal Scientist

High Purity Water Consultant Biopharmaceutical Water Doc

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