Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance (Pharmaceuticals Trai)
|Event Date/Time: Sep 13, 2011||End Date/Time: Sep 13, 2011|
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.
Upon completion of this course the participant should be able to:
Understand the requirements for residual solvents addressed in ICH, USP, EP and JP.
Identify the classes of solvents and address sources of solvents.
Effectively utilize options for describing residual solvents.
Select appropriate analytical procedures.
Utilize strategies to minimize the testing and resources required to meet the requirements.
Report levels of residual solvents appropriately.
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.