World Conference Calendar

35139 Conferences

Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance

Added by Referral on 2011-07-01

Conference Dates:

Start Date Start Date: 2011-09-13
Last Date Last Day: 2011-09-13

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

This course is designed to provide participants with an understanding of the regulatory landscape for residual solvents requirements, including interpretation of the majors sections (classes of solvents, options for describing levels, analytical procedures).

We will discuss controlling residual solvents in incoming materials as well as those introduced during manufacture. We will review analytical procedures for testing of residual solvents and discuss strategies for compliance and reporting of residual solvents levels.

Several frequently asked questions will be addressed, and after the presentation there will be an opportunity for questions and discussion.

Areas Covered in the Seminar:

- Introduction to Regulatory Landscape for Residual Solvents.
- Controlling Residual Solvents in Incoming Materials or - Those Introduced During Manufacturing.
- Analytical Procedures for Residual Solvents: Compendial - Procedures, Alternative Procedures and Reference Standards.
- Strategies for Compliance: Testing and Avoiding Testing.
- Reporting Residual Solvents: Assuring You Address - Regulators' Concerns.
- Frequently Asked Questions, including Feedback from FDA.
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