Webcasts - - BioPharm International

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Webcasts


UPCOMING WEBCASTS

Part 1 - Thursday, May 8, 2008, 1pm - 2pm ET
Part 2 - Wednesday, May 21, 2008, 11am - 12pm ET
Understanding the Standard Setting Process of the United States Pharmacopeia and National Formulary Part 1
Susan Schniepp, President, Schniepp and Associates
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This training series will focus on the standard setting process of the United States Pharmacopeia and National Formulary. This complex process will be broken down into individual elements so the student can understand how the process works, how it impacts their work and how they can participate in the process. In addition, the series will also explore common misinterpretations of the USP General Notices, dissecting a monograph and validation and verification concepts for the methods in the USP/NF.

Wednesday, May 14, 2008
12pm - 1pm ET

Modern approaches to analytical method development and optimization, using literature, intelligent scouting, chemometrics for separations improvement, fully automated methods development in HPLC. Reducing costs through knowledge management
Ira Krull Ph.D., Associate Professor of Chemistry, Northeastern University
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This seminar will discuss modern methods for the identification and charcterization of protein aggregates and multimeric protein associates. The techniques to be emphasized will be static and dynamic light scattering and viscometry, as stand-alone techniques or when coupled with an initial separation step (SEC, GFC, FFF). We will describe the nature of the information possible using these techniques, such as absolute MW, polydispersity, hydrodynamic radius, radius of gyration, weight average MW and so forth. We will also discuss how the results from these light scattering methods can be compared to similar approaches using mass spectrometry.

Tuesday, May 20, 2008
12pm - 1pm ET
Systems Solutions for Governance and Compliance
Terrence Leach, Manager, Regulatory and Capital Markets Consulting
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Most companies have yet to implement a sustainable enterprise wide process to address governance, risk and compliance needs. The heroic efforts of small project teams are implemented as short term solutions in day-to-day activities and many use disparate, manual or non-standardized systems. The result is duplicative efforts when complying with multiple requirements and a lack of accurate, timely and transparent information. This is what made complying to Sarbanes more expensive and time consuming than necessary. Aligning the right technology with your business needs can provide the high quality information required for efficient and effective compliance and governance.


Thursday, June 12, 2008
11am - 12.30pm ET
Quality Systems in a Global Market
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Companies, including virtual companies, are required by regulators to document their Quality System. Companies rely on standard operating procedures to document these systems and define their processes for performing certain functions. Each company has its own set of SOPs, which can create a number of challenges when working in today?s global pharmaceutical market. Differences in regional regulations only add to the confusion.


ARCHIVED WEBCASTS

IT Infrastructure and Network Qualification: Introduction and Strategies for Compliance and System Uptime
Ludwig Huber, Ph.D., Worldwide Compliance Program Manager, Agilent Technologies
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Available through May 26, 2008

Analytical Instrument Qualification (Event 1 of 6)
Michael Swartz, Ph.D., Research Director, Synomics Pharma
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Available through June 20, 2008

Enhancing Tech Transfer from Development into cGMP Operations
Sponsored By Laureate Pharma
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Available through April 28, 2009

Quality Metrics: Reducing costs through knowledge management
Karen Ginsbury, President, PCI Pharmaceutical Consulting Israel Ltd
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Available through May 6, 2009

For questions or more information please contact Jamie Carpenter at
jcarpenter@advanstar.com or call 800-234-4535

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