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  • Residual Solvents - Understanding the Requirements and
    Practical Strategies for Compliance

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Sep 24, 2013 10:00 AM
  • End Time:
  • Tuesday - Sep 24, 2013 12:00 PM
  • Location:
  • Online
  • This training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors sections (classes of solvents, options for describing levels, analytical procedures).

    Why Should You Attend:
    This course is designed to provide participants with practical strategies for complying with regulatory requirements for residual solvents while minimizing resource requirements. The course will address FDA expectations, understanding the potential sources of residual solvents in drug products, appropriate analytical methodology and strategies for characterizing solvents in components and in drug product.
    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.

    Learning Objectives:
    Upon completion of this course the learner 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.
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