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Langue du site : Français - English
Réf : 31945
Evènement :Comprehensive Seminar on Everything You'd Like to Know about Pharmaceutical Water Systems, But were Afraid to Ask

Dates :Jeudi 22 Octobre 2020 - Vendredi 23 Octobre 2020

Lieu :Venue to be announced shortly
Newark, New Jersey, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

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.
 

Objectives

  • 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.


 

Program

Day 01(9:00 AM - 5:00 PM)
  • 9:00 AM- 9:15 AM Registration Meet & Greet.
  • 9:15 AM- 10:00 AM
    • Instrumentation, Measurements, Testing of Source, Pretreatment, and Pharmaceutical Waters
  • 10:00 AM- 10:30 AM
    • Lessons Learned from an In-depth FDA Investigation
  • 10:30 AM- 10:45 AM COFFEE BREAK
  • 10:45 AM- 11:45 AM
    • Microbial Issues and its Mitigation in Pharmaceutical Waters
  • 11:45 AM- 12:30 PM
    • PAT Vs. Traditional Validation
  • 12:30 PM- 1:30 PM Lunch
  • 1:30 PM- 2:30 PM
    • Understanding and Troubleshooting Pharmaceutical Water Systems
  • 2:30 PM- 3:00 PM
    • Possible ideas, approaches, and directions for future production, process, cGMP compliance, and critical utilities
  • 3:00 PM- 3:15 PM COFFEEE BREAK
  • 3:15 PM- 4:00 PM
    • Rouge Monitoring
  • 4:00 PM- 4:45 PM
    • Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
  • 4:45 PM- 5:00 PM
    • Q&A
Day 02(9:00 AM - 5:00 PM)
  • 9:00 AM- 9:15 AM Registration Meet & Greet.
  • 9:15 AM- 10:00 AM
    • Hot water, Chemical, and Ozone Sanitization
  • 10:00 AM- 10:30 AM
    • Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems
  • 10:30 AM- 10:45 AM COFFEE BREAK
  • 10:45 AM- 11:45 AM
    • Non-distillation WFI Options
  • 11:45 AM- 12:30 PM
    • Annex 1 and its Comparison to Compendial Mandates
  • 12:30 PM- 1:30 PM Lunch
  • 1:00 PM- 2:15 PM
    • Myths, Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems
  • 2:15 PM- 3:00 PM
    • Validation of a Pharmaceutical Water System for the 21st Century
  • 3:00 PM- 3:15 PM COFFEEE BREAK
  • 3:15 PM- 4:00 PM
    • Microbial Issues and its Mitigation in Pharmaceutical Waters
  • 4:00 PM- 4:45 PM
    • Sustainability - The Reclaim, Recycle, Reuse and Reduction of Water in Biopharmaceutical Production
  • 4:45 PM- 5:00 PM
    • Q&A


 

Speakers

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.

Organizing committee

Complianceonline
 

Lieu

Plan et itinéraire
Adresse de la conférence :
Venue to be announced shortly
Newark
New Jersey, États-Unis
Plan et itinéraire

Renseignements

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Précisions

Comprehensive Seminar on Everything You'd Like to Know about Pharmaceutical Water Systems, But were Afraid to Ask Pharmacie
pharmaceutical water system, pharmaceutical water testing, pharmaceutical water system design, pharmaceutical water system validation, pharmaceutical water sampling, pharmaceutical water system compliance, pharmaceutical water system training, water for injection paradigm
Professionnels
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Divers

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