Conference Compendium

7th Annual Method Validation

IVT’s Annual Method Development and Validation conferences have become industry’s meeting place to discuss trends, regulatory updates and real world examples in effectively validating test methods for all bio/pharmaceutical products. The conference feature an enhanced focus on method development strategies, as well as incorporating QbD in analytical method development and validation, emphasizing the importance of best practices needed in order to successfully verify the process.

The compendiums will cover how to apply a QbD and risk management approach to method validations, FDA and USP evolving regulations, updating methods to current standards, analytical instrument qualification, and high method development strategies. 

FDA’s New Process Validation Guidance: How Can It Impact Test Method Validation?
Jerry Lanese, Ph.D., President, The Lanese Group LLC

Ensure Method Validation Compliance through Review of FDA Warning Letters
David T. Lin, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.  

Enhancing Analytical Quality Through the Use of UPLC: One Method in Place of Two
Corinne Mounier-Lee, Ph.D, Principal Scientist, Catalent Pharma Solutions

Applying QbD Based on Risk Assessment to Achieve a Fundamental & Practical Understanding of Method Validation
Sue Mecham, Ph.D., Director of Laboratory Operations, Polymer Solutions Incorporated and Cynthia Rancourt, B.ScN., Director of Business Operations, Polymer Solutions Incorporated

Method Transfer: Crossing Multiple Borders
Xiande (Andy) Wang, Ph.D., Principal Scientist, Cordis Corporation, A Johnson & Johnson Company

Analytical Instrument Qualification (AIQ)
Paul St. Jean, Senior Product Marketing Manager, Waters Corporation

Method Development of a Chemical Assay Chemical Assay – Specificity, Accuracy, Specificity, Accuracy, Precision
Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology LLC

Stability Indicating Method Validation: Is It Unique?
Jerry Lanese, Ph.D., President, The Lanese Group LLC

Handling Deviations & Unexpected Results During Method Validation 
Upen Shah, B.S., MBA, Senior Director, Quality Management, Amneal Pharmaceuticals

Acceptance Criteria, Intended Use, Science
Jerry Lanese, Ph.D., President, The Lanese Group LLC 

Verfication of Compendial Procedures
Anne-Marie Alderson, MBA, Quality Engineering Manager, Cook MyoSite Inc.

Documenting Method Validation
Upen Shah, B.S., MBA, Senior Director, Quality Management, Amneal Pharmaceuticals

Effective Change Control in Method Development
Alice Krumenaker, ASQ CQPA CMQ/OE, ASQ Certified Six Sigma Green Belt, Process Manager, Quality Systems, Merial Ltd.

Development and Validation of Analytical Test Methods for Cleaning Samples
Rafail Usatinsky, Ph.D., Analytical Research Manager, Cedarburg Hauser Pharmaceuticals, Inc.

Method Optimization and Validation in the 21st Century
David LeBlond, Ph.D., Principal Research Statistician, Abbott

A Practical and Effective Approach to Producing Useful Method Validation Protocols and Reports
Sue Mecham, Ph.D., Director of Laboratory Operations, Polymer Solutions Incorporated

Setting Biological Product Specifications
David T. Lin, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.

Tackling the Challenging Development and Validation of Peptide Methods
Claire E. Brook, Ph.D., Senior Research Chemist, Covidien 

Use of Statistics for Repeatability, Intermediate Precision and Reproducibility
Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology LLC

Validation of Chromatographic Test Methods
Shreekant Karmarkar, Ph.D., Senior Research Scientist, Global R&D, Baxter Healthcare

Method Development and Validation Using Six Sigma
Alice Krumenaker, ASQ CQPA CMQ/OE, ASQ Certified Six Sigma Green Belt, Process Manager, Quality Systems, Merial Ltd.

How to Conduct the Method Validation with a New IPT (In-Process Testing) Method 
Weifeng (Frank) Zhang, Master of Engineering, Validation Manager, Medarex BMS and Ernest Lee, Master of Science, Senior Manager Facilities and Engineering, Medarex BMS

 

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