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Overview: This 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.

Seminar Content: India Seminar 2012 at Mumbai

Day 1 - 10th September 2012

• Lecture 1: What Makes Water Systems Have Microbial Quality Problems
• Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality
• Lecture 3: Water System Validation by Logic Instead of Tradition
• Lecture 4: Implementing Changes to a Validated System
• Lecture 5: Reducing Water Microbial Excursions & Improving Investigations

Day 2 - 11th September 2012

• Lecture 6: Understanding and Controlling Endotoxin
• Lecture 7: Harmonizing vs. Optimizing Water Microbial Testing for System Quality Control
• Lecture 8: Microbial Enumeration Issues with High Purity Water Systems
• Lecture 10: What USP Does and Doesn't Say about PW,WFI, Pure Steam and Micro Issues.

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 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".

DATE AND VENUE:

10th and 11th September, 2012 at Mumbai

Conference Timings: 9:00 am - 6:00 pm

Price – Rs 22000

Contact Information:

Event Coordinator

Toll free: 1800 425 9409

Phone number: +91 80-3221-3341 / +91 80-3247-3696 /

+91 80-3221-3329.

FAX : +91 80-2642-1483

Email: customersupport@globalcompliancepanel.com

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