India Seminar 2012 at Mumbai - The A to Z's of Microbial Control, Monitoring, and Validation of Pharmaceutical Water Systems by Teri C. Soli October 28, 2012

Overview :
In order to understand the microbiology of a water system, one has to understand biofilms since that is the mode of microbial growth in a water system. There is much hype and fear about water systems biofilms by users and regulators alike who do not understand how they grow, how to effectively control that growth, or even how to monitor their presence. This course will help you understand how microorganisms respond to our efforts (or lack of effort) to control their numbers and even to how we try to count them.

About Speaker:
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com),
and since becoming a full time consultant, has served consumer products and FDA-regulated industries with
training and troubleshooting expertise covering water systems, sterilization, aseptic processing,
microbiological and beta-lactam contamination control, microbiological laboratory operations, and has
served as a pharmaceutical expert witness in several "contamination" litigations.Prior to full time consulting,
he had 25 years of diverse "Big Pharma" operating company experience.
During his 31+ year career he has lectured extensively at conferences, authored numerous papers and
recently written several book chapters related to water system microbiology for USP, PDA and ISPE
publications. He is currently serving in his third five-year term on USP Expert Committees responsible for
Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter <1231> which many
consider to be USP's "pharmaceutical water bible".

Seminar Content:
Day 1 - 29th October 2012

Lecture 1:
Quality Problems
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 myths
Get answers to your own water system questions

Lecture 2: Successful Sanitization Approaches for
Trouble-Free Water Quality
Material and construction limitations
Continuous vs intermittent sanitization
The importance of biofilm removal
How sanitants work (or don't work)
When to sanitize
Troubleshooting sanitization problems

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 "validation”
Minimum validation expectations
How to figure out what you should validate
What happens after the honeymoon is over
Is validation ever really over?
Special considerations for lab water systems
Are packaged waters a viable option?

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 requalification?
What about water use during re-qualifications?
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 Investigations
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 impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Minimizing unnecessary excursion responses through best
practices

Day 2 - 30th October 2012

Lecture 6: Understanding and Controlling Endotoxin
Where does endotoxin come from?
What are the properties of endotoxin?
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 occurred
Water Micro TM "Dis-Harmonization”
A little about Biofilm
Biofilm diversity in water systems
Micro TM options and evaluation protocol
The good and bad of Micro harmonization
Where RMMs can fit in
Parting wisdom

Lecture 8: Microbial Enumeration Issues with High
Purity Water Systems
Biofilm enumeration issues (planktonic vs surface)
Traditional cultivative approach issues
Validation of your test method
Alternative TM choices (advantages/disadvantages)
Significance of water isolates
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?
Starting water issues
Misunderstood issues clarified
Microbiological test issues clarified
Suggested micro test method
Micro Specifications
Alert and Action Levels and max,s
Recent/Upcoming USP water changesDiscrepancies between pharmacopeias
New water initiatives – need your input/feedbac

What you get:
1. Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
5. Special price on future purchase of web based trainings.
6. Special price on future consulting or expertise services.
7. Special price on future seminars by GlobalCompliancePanel.
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,
notepad and pen.
9. Networking with industry's top notch professionals

Professionals who will benefit:
Microbiology Laboratory Supervisors
Analysts Responsible for Water Sampling
Quality Assurance Personnel Responsible for Water System Deviation Management
Regulatory and Compliance Professionals
Process and Utility Engineers Responsible for Water System Maintenance, Troubleshooting, and Excursion Mitigation
Facility Engineers Responsible for Water System Design or Renovation
Validation Personnel for Qualification

Pricing List:

1. Price for One Delegate pass – INR
22000 + 12.36% tax
(Between October 1st to October 28th)

2. Early bird price for one Delegate
pass – INR 20000 + 12.36% tax
(Between August 22th to 30th)

3. Group Delegate pass (5 & above) – 10% discount on total amount.

How to Register:
Step 1: Download the registration form from GlobalCompliancePanel website.
Step 2: Fill in the requested information and fax us or email a scanned copy of the same.
Step 3: Send us the cheque with the purchase document which comes with the registration
form.
Step 4:We will send you a confirmation letter within 1 week after we receive the check.
Step 5: Bring the confirmation letter with you on the 1st day of the seminar and submit it at the
registration counter to receive your seminar kit and join the seminar.

Contact Information:
Event Coordinator
Toll free: 1800 425 9409
Phone number: +91 80-3247-3694 / +91 80-3201-4957
Email: [email protected]
GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
4th Floor, A, Block, Brigade Software Park,
Banashankari 2nd stage,
Bangalore-560070. INDIA.

Conference timings: 9:00 am - 6:00 pm
On 29th and 30th October, 2012 at Mumbai
Intercontinental the Lalit
Sahar Airport road,Andheri west
Mumbai, Maharashtra 400059 INDIA

Official Website: http://bit.ly/Rfiu7o