WebEx Channels » On-demand » 2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation at Washington DC

WebEx Channels

2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation at Washington DC Shared by globalcompliancepanel

2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation at Washington DC


This course is designed to provide a microbiology-focusededucation about all aspects of water systems and how biofilm manages to thrivethere. Prior microbiological education or training, though a plus, is not arequirement because engineers and other non-biologists also need this trainingif they are involved with any aspect of water systems. The instructor willprovide the necessary background needed to understand this very importantsubject matter. This understanding is essential to the proper design, validation,operation, monitoring, maintenance, troubleshooting, and excursioninvestigations of a high purity water system. Without this understanding, watersystem control consists of a set of rules that often don't work and can causevery costly system downtime or even product recalls, and leaves the userwithout a clue as to what went wrong or how to effectively fix it so it doesn'trecur.

Why you should attend:

Much fear and hype exists with pharmaceutical biofilms,especially those in water systems. Long term biofilm control cannot be achievedfrom a blind set of hand-me-down rules for design and operation. One must trulyunderstand biofilm to be able to control it. And because every water system isunique, understanding how biofilm is trying to grow in your system, which couldbe different than any other system. This course will give you thatunderstanding that is translatable to any system, so that uneventful microbialcontrol is possible. Without this understanding you will quickly find thatblind rules for operation (and design) eventually fail to work, and theconsequences of failure will far exceed the educational costs that could haveprevented it.

Course Outline:

Day 1 – Agenda

Lecture 1: What Makes Water SystemsHave Microbial Quality Problems

Lecture 2: Successful SanitizationApproaches for Trouble-Free Water Quality

Lecture 3: Water System Validation byLogic Instead of Tradition

Lecture 4: Implementing Changes to aValidated System

Lecture 5: Reducing Water MicrobialExcursions & Improving Investigations

Day 2 – Agenda

Lecture 6: Understanding andControlling Endotoxin

Lecture 7: Harmonizing vs OptimizingWater Microbial Testing for System Quality Control

Lecture 8: Microbial Enumeration Issueswith High Purity Water Systems

Lecture 9: Water System Investigation"How-To's" and Example Case Studies

Lecture 10: What USP Does and Doesn'tSay about PW, WFI, Pure Steam and Micro Issues


Who Will Benefit:

This 2-day course is particularly relevant tomanagers, supervisors, and operatives taking on new responsibilities related towater, but also for experienced water personnel to learn the "true"whys behind what they do and perhaps better ways of doing things. Specificpositions that would benefit are:

·        Microbiology Laboratory supervisors and analystsresponsible for water sampling and testing

·        Quality Assurance personnel responsible for watersystem deviation management and change control

·        Regulatory and Compliance professionals responsiblefor FDA interactions

·        Process and Utility Engineers responsible for watersystem maintenance, repairs, troubleshooting, and excursion mitigation

·        Facility Engineers responsible for water system designor renovation

·        Validation personnel for water system qualification

·        Change Control personnel involved in water systemchanges and repairs

·        Production Managers involved with water system use formanufacturing and cleaning

·        Laboratory Managers and Supervisors responsible forlab water systems and other water sources


Teri C. Soli

Principal Consultant, Soli Pharma Solutions 

TeriC. ("T.C.") Soli, Ph.D.is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical,Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products andrelated equipment and instrument manufacturing industries with training,auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceuticalexperience as a consultant as well as with operating companies such as DSMPharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli'scareer-long experience with water systems and product and process contaminationtroubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements,afford him practical knowledge and troubleshooting skills with contaminationcontrol, cleaning, sterilization, sterile and non-sterile processes,validation, laboratory testing, excursion investigations and all aspects ofhigh purity water systems. 

Location1: Washington DC | 13th & 14th February 2014| 9:00 AM- 6:00PM

Venue: Courtyard Washington Capitol Hill/Navy Yard

Address: 140 L Street SE - Washington, District Of Columbia 20003 USA

Price: $1,295.00


Register now and save $200. (Early Bird)

Until January 01, Early Bird Price: $1,295.00
from January 02 to February10, Regular Price:


Location2: San Diego CA|1st & 2ndMay 2014 | 9:00 AM- 6:00PM

Venue: DoubleTree by Hilton Hotel San Diego Downtown

Address: 1646 Front Street, San Diego, California, 92101, USA

Price: $1,295.00


Register now and save $200. (Early Bird)

Until February10, Early Bird Price: $1,295.00
from February11 to April28, Regular Price:


Contact Information:
Event Coordinator

Toll free: 1800 4479407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

LIVE CHATSUPPORT - http://www.globalcompliancepanel.com/chat/client.php

EventLink: http://bit.ly/JvIJei

DBA GlobalCompliancePanel, 
161 Mission Falls Lane, 
Suite 216, Fremont, CA 94539, USA 

Add your own webinar

  • Share your own content on WebEx Channels. Upload a WebEx recording or just share a presentation, pdf or document. It’s free!

Get Startedloading
Last-Modified: Wed, 5 Feb 2014 12:13:27 GMT

Report this Event

Please specify why this content is inappropriate(check all that apply)