Residual Solvents: Understanding the Requirements and Practical Advice for Implementing USP /ICH Q3C

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 webinar 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). It will discuss controlling residual solvents in incoming materials as well as those introduced during manufacture. It 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, after the presentation there will be an opportunity for questions and discussion.

Learning Objectives:

Upon completion of this course the participants will 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.
• Utilize strategies to minimize the testing and resources required to meet the requirements.
• Select appropriate analytical procedures when testing is necessary.
• Report levels of residual solvents appropriately.

Areas Covered in the Webinar:

• Introduction: Regulatory Landscape for Residual Solvents
• Implementation and Strategies for Compliance: Testing and Avoiding Testing
• Analytical Procedures for Residual Solvents: Compendial Procedures, Alternative Procedures and Reference Standards
• Reporting Residual Solvents: Assuring You Address Regulators’ Concerns
• Questions and Discussion

Who Will Benefit:

This webinar will provide valuable assistance to all drug companies/manufacturing sites.Those that would benefit most would be:

Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers,

• Regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements
• Laboratory managers and staff
• Analysts
• QA/QCU managers and personnel
• Training department
• Documentation department
• Consultants