LyoLearn Webinars Archive

Table of Contents

• Aggregation of Therapeutic Proteins
• Basic Theory & Practice of Freeze Drying Lecture #4 of 4
• Basic Theory and Practice of Freeze Drying - Lecture #3 of 4
• Basic Theory of Freeze Drying - Lecture 1 of 4
• Basic Theory of Freeze Drying Lecture #2 of 4
• Case Studies in Identifying and Correcting Failed Lyophilized Products (Poor Formulations and or Cycles). Session #2
• Collagen-glycosaminoglycan scaffolds: Lyophilization for wound care applications
• Considerations for the Technology Transfer of Lyophilized Products
• Container Closure Selection for Lyophilized Drug Products
• Containment Solutions for Freeze-Drying / GORE™ LYOGUARD® Freeze-Drying Products
• Cycle Development and Scale-Up Issues for Freeze Dried Products, from Small Molecules to Proteins
• Evaluation of shrinkage temp of bovine pericardium tissue heart valve application by DSC & freeze drying microscopy
• Formulation Development in Freeze Dried Pharmaceuticals
• Freeze Dryer Maintenance and Trouble-Shooting
• Freeze Drying Microscopy: Introduction and Relevance for Process Design
• Freeze Drying of Co-Solvent Systems: Rationale, Opportunities and Applications
• Freeze-Drying of Human Red Blood Cells
• How to Select a Freeze Dryer
• Improving Lyophilization Manufacturing and Development with ContoLyoTM Nucleation On-Demand Technology
• Introducción a La Teoria de Liofilización - En Español
• Introduction to Freeze Drying Theory
• Introduction to the VirTis Encore Control System
• Key Considerations for the Successful Lyophilization of Proteins
• Lyophilization cycle scale up: from development to commercial manufacturing
• Lyophilization of Nucleic Acid-based Pharmaceuticals
• Methods for Evaluating Lyophilized Product in a Laboratory Setting
• Optimization of Freeze-Drying Cycles Using Modulated Differential Scanning Calorimetry (MDSC)
• PAT for Freeze-Drying: Determination of End Point of Primary Drying
• Practical Application of FD Microscopy in Product Thermal Characterization
• Process Analytical Technology (PAT) in Freeze Drying
• Process Development and Scale-up Issues in Freeze Drying
• Quality by Design and Scale-Up Issues in Freeze Drying: The role of controlled ice nucleation
• Quality by Design in Process Development for Freeze-Dried Parenterals
• Rational Design of Stable Lyophilized Protein Formulations
• Scale-Up of Freeze-Drying Cycles: Essential Factors and Transfer Strategies
• SMART Freeze Drying
• The Freeze Drying of Nanoparticles: Fundamentals and Critical Factors
• The Freezing Stage in Freeze Drying: Fundamental Concepts
• The VirTis Encore Control System for Advanced Users
• Troubleshooting Problematic Cycles and Formulations
• Understanding the Physical Properties of Materials in Freeze Dried Products
• Vial Heat Transfer Characteristics: Methodology of Evaluation and Influence on Primary Drying Time

Title:		Freeze-Drying of Human Red Blood Cells
Presenter(s):		Dr. Kevin Ward, Ph.D. MRSC, Director of Research & Development, Biopharma Technology Ltd.
Description:		This webinar examines a study which shows that red blood cells can be successfully freeze dried and rehydrated with minimal degradation. The lessons learned in this study will be applied to further studies on RBC’s and nucleated cells. Read more in the abstract.
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Times:		1/24/2012 - Click Here to View the Webinar Recording

Title:		Practical Application of FD Microscopy in Product Thermal Characterization
Presenter(s):		Ruben J. Nieblas, McCrone Microscopes & Accessories
Description:		During this webinar attendees will be introduced to the components of a freeze drying microscope and its use in determination of thermal characteristics of products to be lyophilized. With the FD Microscope, it is possible to quickly and accurately determine collapse and eutectic temperature and intricately investigate freeze dried structure of complex samples. Light microscopy techniques such as phase contrast and polarized light will be demonstrated.
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Times:		11/28/2011 - Click Here to View the Webinar Recording

Title:		PAT for Freeze-Drying: Determination of End Point of Primary Drying
Presenter(s):		Dr. Sajal M. Patel, Ph.D., Dept. of Formulation Sciences, MedImmune, LLC
Description:		This webinar will compare the various techniques that are currently available to determine the end point of primary drying.
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Times:		10/20/2011 - Click Here to View the Webinar Recording

Title:		Considerations for the Technology Transfer of Lyophilized Products
Presenter(s):		Tim McCoy, Sr Formulation Scientist, Ben Venue Labs
Description:		This webinar presents the challenges of scaling up and transferring a lyophilization cycle from one freeze dryer to another. Recommendations will be made with regards to how to most effectively tranfer your product cycle into another freeze dryer.
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Times:		9/29/2011 - Click Here to View the Webinar Recording

Title:		Aggregation of Therapeutic Proteins
Presenter(s):		Dr. John Carpenter, U of Colorado, School of Pharmacy.
Description:		Aggregation of Therapeutic Proteins: Causes, Control, Consequences and Challenges.  Please see abstract for additional information.
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Times:		8/11/2011 - Click Here to View the Webinar Recording

Title:		Vial Heat Transfer Characteristics: Methodology of Evaluation and Influence on Primary Drying Time
Presenter(s):		Susanne Hibler, U of Erlangen Freeze Drying Focus Group
Description:		This webinar explores heat/mass transfer within a product in a vial and the influence on primary drying.  A methodology for calculating vial heat transfer will be discussed.
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Times:		7/27/2011 - Click Here to View the Webinar Recording

Title:		Case Studies in Identifying and Correcting Failed Lyophilized Products (Poor Formulations and or Cycles). Session #2
Presenter(s):		Dr. J. Jeff Schwegman, AB|Biotechnologies
Description:		Dr. Schwegman looks at freeze dried product for clues as to what may have gone wrong with formulation or the development of the freeze drying product.
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Times:		6/28/2011 - Click Here to View the Webinar Recording

Title:		Lyophilization of Nucleic Acid-based Pharmaceuticals
Presenter(s):		Dr. Tom Anchordoquy, University of Colorado
Description:		The talk will cover the stability of both plasmid DNA and siRNA during lyophilization and storage Please note that if you view the recording Dr. Anchordoquy's discussion has been captured but the powerpoint has not been captured.  We suggest that you download the powerpoint before viewing the recording so you can follow along.
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Times:		5/18/2011 - Click Here to View the Webinar Recording

Title:		Lyophilization cycle scale up: from development to commercial manufacturing
Presenter(s):		Dr. Serguei Tchessalov, Principle Scientist, Pfizer
Description:		This webinar discusses the issues and procedures for moving a freeze drying process from one dryer to another as part of the scale-up procedure.
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Request Presentation Slides:		The focus of this presentation is to show what considerations are required to transfer your freeze drying cycle from one lyophilizer to another and delivers information on how to overcome the hurdles in this process.
Times:		4/20/2011 - Click Here to View the Webinar Recording

Title:		Quality by Design and Scale-Up Issues in Freeze Drying: The role of controlled ice nucleation
Presenter(s):		Dr. Michael Pikal, Professor and Distinguished Chair, Pharmaceutical Technology - University of Connecticut
Description:		Here, we discuss controlled ice nucleation by both the ice-fog technique and the depressurization technique and review the advantages of controlled ice nucleation.
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Times:		4/7/2011 - Click Here to View the Webinar Recording

Title:		Rational Design of Stable Lyophilized Protein Formulations
Presenter(s):		Dr. John Carpenter, Professor or Pharmaceutical Sciences, School of Pharmacy, University of Colorado Co-Director, University of Colorado Center for Pharmaceutical Biotechnology.
Description:		To rationally develop a stable lyophilized protein formulation it is important to understand the means by which different excipients stabilize proteins during freezing, drying, storage in the dried solid, and during rehydration
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Times:		3/17/2011 - Click Here to View the Webinar Recording

Title:		Basic Theory & Practice of Freeze Drying Lecture #4 of 4
Presenter(s):		Presented by Dr. Jeff Schwegman, AB|Biotechnologies
Description:		This is the 4th lecture in a 4 part series.  To view lectures 1 through 3 please visit the LyoLearn Webinar Archive section of our website.
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Times:		2/25/2011 - Click Here to View the Webinar Recording

Title:		Basic Theory and Practice of Freeze Drying - Lecture #3 of 4
Presenter(s):		Presented by: Dr. Jeff Schwegman, AB|Bioltechnologies
Description:		This is the third lecture in a four part series on the Basic Theory and Practice of Freeze Drying.  If you have missed the first two sessions you can view recordings of these sessions in the LyoLearn Webinar Archive section of our website.
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Times:		2/18/2011 - Click Here to View the Webinar Recording

Title:		Basic Theory of Freeze Drying Lecture #2 of 4
Presenter(s):		Presented by Dr. J.Jeff Schwegman, AB|Biotechnologies
Description:		This is the second lecture of a four part series.
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Times:		2/11/2011 - Click Here to View the Webinar Recording

Title:		Evaluation of shrinkage temp of bovine pericardium tissue heart valve application by DSC & freeze drying microscopy
Presenter(s):		Dr. Virgilio Tattini Junior, Department of Biochemical and Pharmaceutical Technology, Pharmaceutical Science School, University of Sao Paulo & Lyohelp Consulting Services
Description:		Full Title: Evaluation of shrinkage temperature of bovine pericardium tissue for bioprosthetic heart valve application by differential scanning calorimetry and freeze-drying microscopy The aim of this work was to compare the results of shrinkage temperature obtained by DSC with the results obtained by freeze-drying microscopy for bovine pericardium bioprosthesis
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Times:		2/9/2011 - Click Here to View the Webinar Recording

Title:		Basic Theory of Freeze Drying - Lecture 1 of 4
Presenter(s):		Dr. Jeff Schwegman, AB|Biotechnologies This is the first lecture of a four part series
Description:		This is a four webinar series that is designed to help participants understand the basic theory of freeze drying. Please see the abstract for course outline.  This is the first of the four lectures given during this series
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Times:		2/4/2011 - Click Here to View the Webinar Recording

Title:		Methods for Evaluating Lyophilized Product in a Laboratory Setting
Presenter(s):		Wendy Sunderland, Lyophilization Technology
Description:		Physical appearance of a lyophilized product can provide significant insight into the attributes of a product and relative effects of processing.  Developing a detailed cake description during the development of a lyophilized product is important in order to discern subtle differences with regards to formulation variations, product designs, processing variables, and the impact of scale-up activities on product appearance.
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Times:		12/15/2010 - Click Here to View the Webinar Recording

Title:		Collagen-glycosaminoglycan scaffolds: Lyophilization for wound care applications
Presenter(s):		Dr. Brendan Harley, Dept. of Chemical and Biomolecular Engineering, University of Illinois at Urbana-Champaign
Description:		Here we describe the fabrication, and characterization, and modeling of a series of non-mineralized and mineralized CG scaffolds. We then discuss their use in vivo to induce tissue regeneration following injury and in vitro as standardized 3D materials to study the influence of microstructural and mechanical features on cell behaviors such as motility and contraction
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Times:		11/17/2010 - Click Here to View the Webinar Recording

Title:		Container Closure Selection for Lyophilized Drug Products
Presenter(s):		Eugene T. Polini, III and Ronald L. Mueller, Ph.D., West Pharmaceutical Services, Inc.
Description:		The selection of a primary parenteral package significantly influences the stability of lyophilized drug products. Moisture ingress can cause degradation of those products. Several chemical and physical attributes to minimize moisture ingress and manufacturing issues will be discussed.
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Times:		10/26/2010 - Click Here to View the Webinar Recording

Title:		Quality by Design in Process Development for Freeze-Dried Parenterals
Presenter(s):		Lisa Hardwick, Research Scientist, Baxter Healthcare Dr.Steven Nail, Sr. Baxter Research Scientist.  Baxter Phamaceutical Solutions LLC
Description:		We will present a case study to illustrate one approach that includes the essential elements of QbD.
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Times:		9/15/2010 - Click Here to View the Webinar Recording

Title:		Key Considerations for the Successful Lyophilization of Proteins
Presenter(s):		Jeff Blue, Merck
Description:		The following presentation will discuss factors that should be considered when choosing lyophilization over liquid formulations and the critical lyophilization parameters which should be understood, monitored, and controlled.
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Times:		8/26/2010 - Click Here to View the Webinar Recording

Title:		Freeze Drying of Co-Solvent Systems: Rationale, Opportunities and Applications
Presenter(s):		Hans de Waard, Department of Pharmaceutical Technology and Biopharmacy University of Groningen Groningen, the Netherlands
Description:		Co-solvents can be used during freeze drying to optimize the freeze drying cycle or to freeze dry other compounds than usually used. By understanding what happens during freeze drying within the solution, it is possible to manipulate the process to obtain a product with the desired physico-chemical properties.
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Times:		7/20/2010 - Click Here to View the Webinar Recording

Title:		The VirTis Encore Control System for Advanced Users
Presenter(s):		Amanda Bradley, Techncial Sales Representative, SP Scientific
Description:		This webinar is intended for those people who have or are planning to own the VirTis Encore and want to optimize their use of this control platform. This presentation is only available as a recorded session.  No power point presentation is available.
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Times:		6/24/2010 - Click Here to View the Webinar Recording

Title:		Scale-Up of Freeze-Drying Cycles: Essential Factors and Transfer Strategies
Presenter(s):		Dr. Stefan Schneid. PhD., University of Erlangen, IPT, Freeze-Drying Focus Group
Description:		This webinar will discuss the scale-up procedure for freeze-drying processes with special consideration of critical product parameters and environmental factors.
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Times:		6/17/2010 - Click Here to View the Webinar Recording

Title:		Introduction to the VirTis Encore Control System
Presenter(s):		Amanda Bradley, Technical Sales Representative, SP Scientific
Description:		This webinar is an introduction to the features and the use of the VirTis Encore control system.  It is intended primarily for new users and those people interested in investigating the possible use of the Encore. This presentation is only available as a recorded session.  No power point presentation is available.
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Times:		5/27/2010 - Click Here to View the Webinar Recording

Title:		Improving Lyophilization Manufacturing and Development with ContoLyoTM Nucleation On-Demand Technology
Presenter(s):		Dr. Robert Sever, Ph.D., BioPharma Research & Development, Praxair, Inc
Description:		This webinar will discuss the use of Praxair ContoLyoTM Nucleation On-Demand Technology to create uniform and repeatable ice nucleation characteristics of products to be freeze dried.
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Times:		5/13/2010 - Click Here to View the Webinar Recording

Title:		Troubleshooting Problematic Cycles and Formulations
Presenter(s):		Dr. Jeff Schwegman, PhD, Founder, CEO, AB BioTechnologies
Description:		By understanding the thermal characteristics of the formulated product, it is possible to troubleshoot and correct problems with either the product formulation or the lyophilization cycle itself.
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Times:		4/20/2010 - Click Here to View the Webinar Recording

Title:		Optimization of Freeze-Drying Cycles Using Modulated Differential Scanning Calorimetry (MDSC)
Presenter(s):		Dr. Steve Aubuchon, PhD, Product Manager, TA Instruments-Waters, LLC
Description:		MDSC is a primary tool for the characterization of freeze-concentrated solutions, and the subsequent optimization of lyophilization cycles. MDSC is also used to characterize lyophilized product providing additional information regarding product stability.
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Times:		3/25/2010 - Click Here to View the Webinar Recording

Title:		Containment Solutions for Freeze-Drying / GORE™ LYOGUARD® Freeze-Drying Products
Presenter(s):		Mr. Fred Giordano, W. L. Gore & Associates, Inc.
Description:		This webinar will introduce the integration of microfiltration technology and single-use disposables, as a means to contain and protect product before, during and after freeze-drying. View GORE™ LYOGUARD®
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Times:		2/8/2010 - Click Here to View the Webinar Recording

Title:		The Freeze Drying of Nanoparticles: Fundamentals and Critical Factors
Presenter(s):		Jakob Beirowski, University of Erlangen
Description:		This webinar will outline process and formulation strategies and illustrate critical factors which must be considered when freeze-drying nanoparticulate formulations.
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Times:		1/21/2010 - Click Here to View the Webinar Recording

Title:		Freeze Dryer Maintenance and Trouble-Shooting
Presenter(s):		David T. Sutherland, former VP Engineering VirTis (ret.); Matt Dellinger, Senior Service Engineer VirTis and FTS Lyophilizers
Description:		Maintaining the lyophilizer and all of its major systems are key to freeze-dryer longevity and enhanced productivity.
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Times:		12/15/2009 - Click Here to View the Webinar Recording

Title:		Cycle Development and Scale-Up Issues for Freeze Dried Products, from Small Molecules to Proteins
Presenter(s):		Dr. Kevin Ward, PhD, Director of R&D Biopharma Technology Ltd.
Description:		This Webinar will outline how various methods of formulation characterization, laboratory scale trials and approaches to robustness testing can contribute to the achievement of a quality lyophilized product that will survive the scale-up process.
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Times:		11/18/2009 - Click Here to View the Webinar Recording

Title:		Introducción a La Teoria de Liofilización - En Español
Presenter(s):		Gina Galan, SP Industries
Description:		La introducción a la teoria de liofilización les ofrecerá un breve resúmen de los precesos en liofilización, una descripción básica de los equipos que se requieren para que dicho proceso ocurra y la cobertura de aplicaciones típicas en dicha area. Para preguntas comuniquese con Gina Galan - gina.galan@spindustries.com
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Times:		11/11/2009 - Click Here to View the Webinar Recording

Title:		Understanding the Physical Properties of Materials in Freeze Dried Products
Presenter(s):		Dr. Jeff Schwegman, PhD, Founder/CEO AB BioTechnologies
Description:		This webinar presents the relevant scientific principles and discusses how the physical properties of the formulation and the lyophilization process affect the cost, stability, and efficacy of the loyphilized product.
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Times:		10/29/2009 - Click Here to View the Webinar Recording

Title:		Process Analytical Technology (PAT) in Freeze Drying
Presenter(s):		Mr. Stefan Schneid, PhD candidate, University of Erlangen
Description:		This webinar will outline the importance of Quality by Design for Lyophilization and discuss conventional as well as novel approaches for the use of PAT.
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Times:		9/24/2009 - Click Here to View the Webinar Recording

Title:		Process Development and Scale-up Issues in Freeze Drying
Presenter(s):		Mr. Sajal Patel, PhD candidate, University of Connecticut; Dr. Michael Pikal, University of Connecticut
Description:		There exist a number of manufacturing challenges which need to be taken into consideration during lyophilization cycle development and scale-up. This webinar will discuss the importance of heat and mass transfer in the design of a rational freeze drying process.
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Times:		8/11/2009 - Click Here to View the Webinar Recording

Title:		Formulation Development in Freeze Dried Pharmaceuticals
Presenter(s):		Mrs. Adora Padilla, University of Connecticut & KBI BioPharma
Description:		This webinar will discuss the development of a stable freeze dried formulation through appropriate selection of stabilizers and excipients.
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Times:		6/21/2009 - Click Here to View the Webinar Recording

Title:		Freeze Drying Microscopy: Introduction and Relevance for Process Design
Presenter(s):		Ms. Susanne Rutzinger, PhD candidate, University of Erlangen
Description:		Controlling the product temperature at the sublimation interface close to the critical formulation temperature is the key to an optimized cycle design. This webinar will illustrate the important role of freeze dry microscopy in finding a compromise between process time and product quality. For information on Linkam Freeze Drying Microscopy systems, please click here: Linkam Freeze Drying Microscopy
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Times:		6/19/2009 - Click Here to View the Webinar Recording

Title:		Introduction to Freeze Drying Theory
Presenter(s):		Ms. Leslie Mather, SP Industries; Mr. John Barley, SP Industries
Description:		Introduction to Freeze Drying Theory is a brief overview of the lyophilization process, including a basic description of the equipment used and a discussion of typical applications.
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Times:		5/28/2009 - Click Here to View the Webinar Recording

Title:		How to Select a Freeze Dryer
Presenter(s):		Mr. Paul Coiteux, SP Industries
Description:		This webinar will address how to select the correct Lyophilizer for an application. While some considerations will be more general, focus will be on freeze dryers which utilize shelf temperature control.
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Times:		5/20/2009 - Click Here to View the Webinar Recording

Title:		The Freezing Stage in Freeze Drying: Fundamental Concepts
Presenter(s):		Dr. Henning Geiseler, University of Erlangen
Description:		An important goal of the freezing step is to produce a homogeneous batch with regard to the ice crystal size distribution. The scope of this webinar is to provide an insight into the fundamental concept of the freezing stage in a freeze drying cycle
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Times:		4/29/2009 - Click Here to View the Webinar Recording

Title:		SMART Freeze Drying
Presenter(s):		Ms.Leslie Mather, SP Industries; Dr.Henning Geiseler, University of Erlangen
Description:		Reducing Cycle Optimization Time and Costs using SMART Freeze Dryer Technology
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Times:		1/28/2009 - Click Here to View the Webinar Recording

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