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Water - Global Regulatory Changes and Impact on Your Company Evening Meeting

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Host: Mark Mourey, Director Business Development, CRB
Program Manager: Paul Crissman, Principal, Biotechnical Solutions

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Background

  1. The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. New sections on scope, utilities, environmental monitoring, and process monitoring; a reorganized and restructured content for a more logical flow; and the introduction of QRM principles make the new and improved Annex 1 critically important for the pharmaceutical industry.
  2. European Pharmacopeia recently changed to allow membrane as well as distillation for water production.
  3. ISPE Baseline Guide for Pharmaceutical Water Systems Revision 3 to be released shortly

Event Details


Speakers

Nissan Cohen, Sales Director, Aqua-Chem, USA -- an ISPE member since 1994, is a worldwide expert in total organic carbon, high purity, ultrapure, reclaim-and-recycle water systems, with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. He is also the co-chairman of the ISPE Baseline Guide revision for Water and Steam Systems.

Jarrod Wrampe, Process Utilities Engineer, CRB -- has over 17 years of experience as a process utility engineer and project manager at CRB. His current design duties include the development of process and instrumentation diagrams (P&IDs), equipment specifications, equipment plans, piping plans and architectural drawings. Jarrod frequently functions as the client’s primary interface for both design and project management. Jarrod’s experience as a design lead and project manager allow him to understand the entire project from inception to completion across multiple disciplines, making him an integral part of every phase of the design team.


Schedule

4:00 - 5:00 pm Registration and Networking

5:00 - 5:30 pm Appetizers and Networking

5:30 - 6:00 pm European Pharmacopeia Changes to Water Production
Speaker: Jarrod Wrampe, Process Utilities Engineer, CRB

6:00 – 6:50 pm Annex 1
Who is Responsible - What is the Enforcement - What it means to your Company Updating the Baseline Guide for Pharmaceutical Water Systems Speaker: Nissan Cohen, Sales Director, Aqua-Chem, USA

6:50 - 7:00 pm Q&A


Location

CRB

100 N. Pacific Coast Highway, Suite 600

El Segundo CA 90245


Sponsors 

 

 

 

 

 

 

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