Residual Solvents Testing: How to Apply USP

Venue: Holiday Inn Somerset

Location: Somerset, New Jersey, United States

Event Date/Time: May 19, 2010 End Date/Time: May 20, 2010
Registration Date: May 19, 2010
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Description

One & a half-day Interactive Training Seminar
At the end of the course, the students will have an understanding of the regulatory requirements regarding residual solvents, will have practical information about how to apply the specifications and when testing is required, will be familiar with the USP methodology and when alternative methods are appropriate and will be able to verify or validate the methods to be used in their laboratory.

Questions and discussion are strongly encouraged throughout the course. This will enable participants to benefit from one another’s experiences, as increasing the engagement of the participants.

One & a half-day Course & Workshop on:

History of requirements for Residual Solvent analysis
FDA, ICH and European General Requirements for Residual Solvents
ICH Q3C Impurities: Guideline for Residual Solvents
FDA Expectations for Reporting Residual Solvent Data
How to Implement Newest USP Chapter <467> Residual Solvents
Applying USP Chapter <467> to APIs, Excipients, and OTC Products
Risk Based Strategies and Approaches to Minimize Testing
Analytical Procedures Contained in Chapter <467>
Setting Residual Solvent Specifications and Evaluating Data against Limits
Options 1 and 2 for Determining Levels of Class 2 Residual Solvents in Drug Products
Developing and Validating Analytical Methods for Residual Solvents Testing
USP Method Details - Procedures A, B, and C - Methodology and Validation requirements
Managing Contract Laboratories and Suppliers with <467> Implementation
Understanding Impact and Changes to Manufacturing and Testing Methods
Quantitative tests vs. limit tests: when to apply which with decision tree
Using test results and other information provided by suppliers
USP'S Elemental Impurities Initiative Current Status
Case Study:

Introduction to Headspace GC

This presentation will mostly cover the development, validation and transfer of headspace GC methods for residual solvent testing

Venue

195 Davidson Avenue
Somerset
New Jersey
United States
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