2-day In-person India Seminar on The A to Z's of Microbial Control, Monitoring, and Validation of Pharmaceutical Water Systems at Mumbai
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.
- (1888PressRelease) October 29, 2012 - 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.
Course Outline: Day 1 Course Outline: Day 2se Outline: Day 2
Lecture 1: What Makes Water Systems Have Microbial Quality Problems Lecture 6: Understanding and Controlling Endotoxin
Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
Lecture 3: Water System Validation by Logic Instead of Tradition Lecture 8: Microbial Enumeration Issues with High Purity Water Systems
Lecture 4: Implementing Changes to a Validated System Lecture 9: Water System Investigation "How-To's" and Example Case Studies
Lecture 5: Reducing Water Microbial Excursions & Improving Investigations 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 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
Contact Information:
Event Coordinator
Toll free: 1800 425 9409
Phone number: +91 080-3247-3694 / +91 80-3201-4957 /+91 80-2642-1483
FAX: +91 80-2642-1483
Email: customersupport ( @ ) globalcompliancepanel dot com
Website: https://www.globalcompliancepanel.com
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