2 Day In Person India Seminar On The A To Z S Of Microbial Control Monitoring And Validation Pharmac - USAprice: contact company for price
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 <1231> 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
Toll free: 1800 425 9409
Phone number: +91 080-3247-3694 / +91 80-3201-4957 /+91 80-2642-1483
FAX: +91 80-2642-1483
NetZealous Services India Pvt. Ltd.
4th Floor, A, Block, Brigade Software Park,
Banashankari 2nd stage,
2 Day In Person India Seminar On The A To Z s Of Microbial Control Monitoring And Validation Pharmac
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