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2 Day In Person India Seminar On The A To Z S Of Microbial Control Monitoring And Validation Pharmac - USA

price: contact company for price

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 <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

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.com

Website: https:www.globalcompliancepanel.com


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Bangalore-560070. INDIA.

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2 Day In Person India Seminar On The A To Z s Of Microbial Control Monitoring And Validation Pharmac

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  • Address: 1000 N West Street, Wilmington, DE, USA

  • Email: Email

Published date: October 17, 2012 -

  • Business Description: GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

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