Conference Details

Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.) Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11) Examples of Typical Approaches for Excel Validation How to tailor your risk based methodology to Excel to determine the level of validation required

Date :

Place : United States, Fremont

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Contact Person:Event Manager

Description:

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.) Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11) Examples of Typical Approaches for Excel Validation How to tailor your risk based methodology to Excel to determine the level of validation required will be held in Fremont,United States on date 2019-01-15

Deadline for abstracts/proposals : 15th January 2019

Organized By :Traininng.com LLC

Keynote Speakers : T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. His career-long water systems and contam

Conference Highlights :Why water myths develop Impact of c-GMPs Well-meaning but misguided precedents Scientifically unchallenged traditions and benchmarking Rule-hungry culture Water System Microbial Control Myths WFI from RO Turbulent Flow and Flow Rate Dead Leg Rules Smooth Surfaces In-Line Sterilizing Filters Ozone Microbial Enumeration Myths Referee Methods Thermophiles in Hot Systems R2A, 35°C, 5 days Test Filter Membrane Rating Compendial Action Levels TOC and Endotoxin as Microbial Count Cor

Venue :Fremont, CA, USA

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Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.) Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11) Examples of Typical Approaches for Excel Validation How to tailor your risk based methodology to Excel to determine the level of validation required

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