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| Category |
Health: Professions
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| Contact |
420 Highway #7 East, Box 82022
Richmond Hill, Ontario
Canada L4B 3K0
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| Description |
A Two 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. Topics include:
A Two-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
Day Two Workshops:
Development of Headspace GC Methods for Residual Solvent Testing
Developing a Checklist: Implementing USP <467> Residual Solvent Analysis
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| Additional Information |
$685.00 CAD + GST
Group Discount: Register three or more delegates for the same course at the same time and receive 10% off the registration fees.
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