Thursday February 23, 2012
LIVE Webinar
Pharmaceutical Water Sampling and Use: How to Reflect Reality, Prevent Problems, and the Possibility of Real-Time Release
Live Webinar
Date: Wednesday February 8, 2012  
Registration Single Attendee: CAD $195.00
Group rates are available. (see below)

All rates are subject to the Canadian 13% Harmonized Sales Tax (HST)
Time: 11:00 AM ET | 8:00 AM PT Duration: 2 hours
Introduction

Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations.  Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly inconclusive problem investigations.  At the heart of the problem is a fundamental misunderstanding of the purposes and practice of sampling and testing, and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise, particularly from biofilm-related contamination. This presentation will correct these misunderstandings and explain practical best practices for outlet use and sampling, including grab samples and on-line testing, that could facilitate the adoption of dramatic resource saving Real-Time Release approaches for BOTH chemistry and microbiological attributes of these waters.

  • Importance of proper sampling
  • Process or Raw Material?
  • Uses of water sampling data
  • Impact on sampling location for
    • Chemical testing
    • Endotoxin testing
    • Microbial testing
  • Impact on microbial sampling technique
  • Sampling plan options
  • Test method options
  • Impact on real time release
Learning Objectives
  • Dispel mistaken paradigms regarding the purpose of sampling
  • Understand how to eliminate sampling variability – the cause of most deviations
  • Understand how to best deliver water from a high purity water distribution system
  • Capitalize on the advantages of on-line analytical instrumentation
  • Understand the value and limitations of rapid microbiological methods as replacements for slow cultural approaches
  • Understand what it would take to transition to Real-Time Release of water
Who Should Attend

This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty.  This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to water:

  • Quality Assurance
  • Quality Control (Chem and Micro)
  • Process and Design Engineering
  • Process Automation
  • Manufacturing Operations
  • Validation
  • Utility Operations
  • Regulatory Affairs.
Speaker

Dr. Teri C. ("T.C.") Soli
President
Soli Pharma Solutions, Inc.

Dr. Teri C. ("T.C.") Soli is President of Soli Pharma Solutions, Inc. serving the pharmaceutical, biological, medical device and cosmetics/personal care products industries with troubleshooting, auditing, and training expertise covering water systems, sterilization, aseptic and non-sterile processing, contamination control, and microbiological laboratories.  His Ph.D. in Microbiology & Immunology supplements his 31+ years of combined consulting and operating company pharmaceutical experience including with Pfizer, Burroughs Wellcome, and DSM Pharmaceuticals. Dr. Soli’s career-long water systems involvements and participation with water-related industry committees with PhRMA, USP, ISPE and PDA, coupled with his extensive lecturing experience afford him practical knowledge of all aspects of high purity water systems and pharmaceutical process contamination control. He is a 3-term member of USP Expert Committees responsible for Pharmaceutical Waters and has authored numerous papers, several PDA and ISPE-sponsored book and industry guide chapters and co-authored all water related USP Monographs, and Chapter revisions since 1996 when USP published the now globally used Water Conductivity and TOC changes for Purified Water and WFI.  Dr. Soli is the author of the 2005- complete rewrite of USP’s “water bible”, Chapter <1231>.   

Rates

Single Attendee: CAD $195.00

Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00

Single attendee refers to single participant at a single computer/login.

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.

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