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Everything You'd Like to Know about Pharmaceutical Water Systems

Oct 22, 2020 - Oct 23, 2020
Everything You'd Like to Know about Pharmaceutical Water Systems

Time Thu Oct 22 2020 at 08:00 am to Fri Oct 23 2020 at 04:30 pm

Newark, United States

USD 1,699
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Everything Youd Like to Know about Pharmaceutical Water Systems Everything You'd Like to Know about Pharmaceutical Water Systems
This course emphasizes the mitigation of microbials in Purified Water and WFI water systems.

About this Event

This course is a comprehensive training on pharmaceutical water systems encompassing over 15 different course subject and modules. The modules include design, build, installation, validation, regulatory compliance, regulatory audit expectations, documentation expectations, modules on continuous electrodeionization (CEDI), ozone, reverse osmosis (RO), distillation methods, pure steam generation, pretreatment options, microbial mitigation and sanitization methods, raw water and sourced water criteria, instrumentation for both observational and compendial criteria, and automation expectations.

Microbial mitigation is one of the most important aspects for purification systems. This course emphasizes the mitigation of microbials in Purified Water and WFI water systems. Profiling microbials in pretreatment systems is a non-compendial exercise. There is a contentious debate about microbial counts in the pretreatment system and whether investigations should be conducted to find microbials considered part of the “bad bug” list. Profiling microbials in the pretreatment and whether this operation is warranted or not due to the new ISO-22519. How ISO-22519 applies to compendial compliance or not.

Modules will be given on WFI water systems produced by non-distilled means using a variety of purification modules to achieve WFI quality. Depiction of different production options for non-distilled WFI is will offered and analyzed. Additionally there will be an overview module on the Baseline Guide for Water and Steam Systems, the most comprehensive guide on pharmaceutical water and steam systems in existence.

Learning Objectives:

You will learn and understand the following:

  • Pharmaceutical Water systems
  • The operations of a pharmaceutical water system
  • The basic chemistry involved in water purification
  • The options of choosing properly defined equipment for individual purification steps
  • The issues of microbial monitoring and sampling
  • The value of different sanitization methods used in pharmaceutical water systems
  • The difference of gram-negative and gram-positive bacteria and their influence in biofilm development
  • The configuration of CEDI, EDI, and Ion Exchange is removing ions from the water
  • The usage of microfiltration (MF), ultrafiltration (UF), and nanofiltration (NF)
  • All modules used in pharmaceutical water production from source water to finished product water supplied to production.
  • The different regulatory, pharmacopeial, and international regulatory issues associated with pharmaceutical water.
  • What lessons can be learned from a regulatory audit or investigation.
  • The usage of Statistical Process Control and Exponentially Weighted Process Statistics to monitor and control your water system long before it hits an action or alert limit.
  • The usage and production of non-distilled WFI.

Who will benefit:

Pharmaceutical, Over-the-Counter, Beauty, Nutraceutical, Biotechnology, and medical device industry professionals in engineering, critical utilities, technical competencies, maintenance, quality control, quality assurance, engineering management, global responsible production personnel.

Speaker:

Nissan Cohen

Owner, Biopharmaceutical Water Doc

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.

For Registration:

https://www.complianceonline.com/microbial-mitigation-of-pharmaceutical-water-systems-seminar-training-80640SEM-prdsm?channel=eventbrite





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Tickets

Tickets for Everything You'd Like to Know about Pharmaceutical Water Systems can be booked here.

Ticket Information Ticket Price
Seminar One Registration (Early Bird) USD 1,699
Seminar One Registration USD 2,099
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Event Information

Date & Time

Thu Oct 22 2020 at 08:00 am to Fri Oct 23 2020 at 04:30 pm

Location

Newark, United States

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