2-day In-person India Seminar on The A to Z's of Microbial Control, Monitoring, and Validation of Pharmaceutical Water Systems at Mumbai

Overview:
Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Day 1 - 29th October 2012
Lecture 1: What Makes Water Systems Have Microbial 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?
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 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 changes
Discrepancies between pharmacopeias
New water initiatives - need your input/feedback
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
About the 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 which many consider to be USP's "pharmaceutical water bible".

Date and Venue:
October 29th and 30th, 2012 at Mumbai
The Leela Kempinski Mumbai Sahar, Andheri Mumbai,India
Price: INR 20,000.00 (for 1 attendee)
Register for 4 Participants to Get 1 Free Pass

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