Two-day in-person India seminar on the A to Zs 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.
Course outline: day one
Lecture 1: what makes water systems have microbial quality problems
Lecture 2: successful sanitisation 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 and improving investigations
Course outline: day two
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 9: water system investigation "how-to's" and example case studies
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 <1231> which many consider to be USP's "pharmaceutical water bible".
Date and Venue:
29 - 30 October 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:
Website: https://www.globalcompliancepanel.com
GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
4th Floor, A, Block,Brigade Software Park,
Banashankari 2nd stage,
Bangalore-560070. INDIA.
Date: 29 October 2012
to 30 October 2012
Time: 10:00 - 18:00
Venue: The Leela Kempinski Mumbai Sahar,Andheri Mumbai,India, Mumbai
Cost: $382.00
More info: 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