Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
Duration : 90 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.
This course focuses on recent changes to USP <467> which can increase flexibility and reduce workload for testing of residual solvents in raw materials and finished products. It addresses options such as whether to test raw materials or drug products, whether to use USP or alternate testing methods, when to screen for all solvents and when to test for specific solvents. Significant resources can be saved by reduced testing, and we discuss the steps necessary to do this successfully.
We’ll explain how new information on verification or validation of analytical procedures clarifies what must be done. We also talk about some of the unresolved challenges related to residual solvents compliance. There will be ample opportunity for questions and discussion.
Course Objective:
Upon completion of this course the learner should be able to:
• Understand the requirements for residual solvents addressed in ICH, USP, EP and JP.
• Take advantage of the flexibility introduced in the revisions to USP <467>
• Utilize strategies to minimize the testing and resources required to meet the requirements
• Verify the USP procedure (or validate alternatives) in accordance with expectations
Course Outline:
• Regulatory Landscape for Residual Solvents: ICH, USP, EP and JP
• Revision to USP <467>: improved clarity and flexibility
• Discussion on various approaches to compliance, and how to minimize resources
• Unresolved issues: solvents with poor volatility or not yet addressed
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Control Personnel
• R&D Scientists
• Laboratory Supervisors and Managers
• Quality Assurance Personnel
• Chemists/Managers
• CMC or Regulatory Affairs Personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
