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Water System Validation in Pharmaceuticals Industry 2017

Monday, Apr 10, 2017 at 9:00AM - Tuesday, Apr 11, 2017 at 6:00PM

Taj Banjara

  • Apr 2017

    10 Mon


  • Apr 2017

    11 Tue


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Water System Validation in Pharmaceuticals Industry 2017

Monday, Apr 10, 2017 at 9:00AM - Tuesday, Apr 11, 2017 at 6:00PM

Hyderabad, CA

No tickets available


course is designed to provide a microbiology-focused education about all aspects
of water systems and how biofilm manages to thrive there. Prior microbiological
education or training, though a plus, is not a requirement because engineers
and other non-biologists also need this training if they are involved with any
aspect of water systems. The instructor will provide the necessary background
needed to understand this very important subject matter. This understanding is
essential to the proper design, validation, operation, monitoring, maintenance,
troubleshooting, and excursion investigations of a high purity water system.
Without this understanding, water system control consists of a set of rules
that often don't work and can cause very costly system downtime or even product
recalls, and leaves the user without a clue as to what went wrong or how to
effectively fix it so it doesn't recur.

Why should
you attend?

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

Who will

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

  • Microbiology Laboratory
    supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel
    responsible for water system deviation management and change control
  • Regulatory and Compliance
    professionals responsible for FDA interactions
  • Process and Utility Engineers
    responsible for water system maintenance, repairs, troubleshooting, and excursion
  • Facility Engineers
    responsible for water system design or renovation
  • Validation personnel for
    water system qualification
  • Change Control personnel
    involved in water system changes and repairs
  • Production Managers involved
    with water system use for manufacturing and cleaning
  • Laboratory Managers and
    Supervisors responsible for lab water systems and other water sources


Day One

Lecture 1:

What Makes Water Systems Have Microbial Quality

  • Understand biofilm basics and
    how it develops
  • Understand the impact of
    biofilm on the commonly used purification unit operations
  • Understand how various
    commonly used microbial control strategies work (or don't work) to control
    biofilm development
  • Understand the how, where,
    and why of microbial monitoring, action levels, etc.
  • Debunk a few water system
  • Get answers to your own water
    system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free
Water Quality

  • Material and construction
  • Continuous vs intermittent sanitization
  • The importance of biofilm
  • How sanitants work (or don't
  • When to sanitize
  • Troubleshooting sanitization

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water
    systems before you validate them
  • Micro Test Method
  • Minimum validation
  • How to figure out what you
    should validate
  • What happens after the
    honeymoon is over
  • Is validation ever really
  • Special considerations for
    lab water systems
  • Are packaged waters a viable

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control
    program - a help, not a hindrance
  • When is a change major vs
    minor, requiring full vs limited re-qualification?
  • What about water use during
  • FDA validation expectations
  • Reliance on logic and common
    sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving

  • What are excursions?
  • Water system dilemma: process
    control or quality control (utility or raw material), or both
  • Intended roles of
    Alert/Action Levels and Specifications
  • Investigation, necessary and
    often fruitless
  • Excursion responses and
  • Criticality of valves, hoses,
    & outlet flushing
  • Diagnosing the source of the
  • Minimizing unnecessary
    excursion responses through best practices

Day Two

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come
  • What are the properties of
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs
    for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for
System Quality Control

  • Water harmonization that has
  • Water Micro TM
  • A little about Biofilm
  • Biofilm diversity in water
  • Micro TM options and
    evaluation protocol
  • The good and bad of Micro
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water

  • Microbial Enumeration Issues
    with High Purity Water Systems
  • Biofilm enumeration issues
    (planktonic vs surface)
  • Traditional cultivative
    approach issues
  • Validation of your test
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water
  • Sampling issues
  • Establishing Alert/Action
    Levels and Water Specs and defending them to FDA

Lecture 9:

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

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn't Say about PW, WFI, Pure
Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max's
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia's


Teri C. Soli, Ph.D.

Principal Consultant, Soli Pharma

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma
Solutions, Inc. offering training, auditing, and troubleshooting expertise
covering water systems, contamination control, sterilization, aseptic
processing, and microbiological laboratories. He has 38 years of pharmaceutical
experience as a consultant and with operating companies including DSM
Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

Dr. Soli's career-long water systems and contamination
troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee
involvements, afford him practical knowledge about process and contamination
control; cleaning, sterilization and process validation; and all aspects of
high purity water systems.

He is beginning his fourth 5 year term on USP Expert Committees
responsible for Pharmaceutical Water, previously served 5 years on the Advisory
Panel to the USP Microbiology Subcommittee, and helped develop the Water
Conductivity and TOC specifications used by USP and adopted world-wide as well
as coauthor USP's comprehensive "water bible', Chapter <1231>
"Water for Pharmaceutical Purposes". As a recognized global expert in
contamination and biofilm control in the pharmaceutical setting and
accomplished presenter, Dr. Soli speaks at numerous conferences and webinars.
He has authored numerous articles in Pharmacopeial Forum and other publications
as well as chapters in books and industry guides published by PDA and ISPE.

Location:Hyderabad, India Date:April 10th & 11th, 2017 and Time: 9:00
AM to 6:00 PM


Venue: Taj Banjara

Address: Road
No.1, Banjara Hills, Mithila Nagar, Banjara Hills, Hyderabad, Telangana 500034,




Register now and save ₹ 2000. (Early Bird)


Price: ₹ 14,000 (Seminar for
one Delegate)


Until March
15, Early Bird Price: 14,000 from March 16 to April 08, Regular Price: 16,000

Registration Details:

NetZealous - GlobalCompliancePanel

NetZealous Services India
Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, 
Bangalore - 560078 Karnataka, INDIA

Phone:  1800 425 9409 

Fax:  080-25149544

Registration Link –

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