Description:
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 . It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.
Why Should You Attend:
This course focuses on recent changes to USP 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.
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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.
- Take advantage of the flexibility introduced in the revisions to USP
- Utilize strategies to minimize the testing and resources required to meet the requirements
- Verify the USP procedure (or validate alternatives) in accordance with expectations
Areas Covered in the Webinar:
- Regulatory Landscape for Residual Solvents: ICH, USP, EP and JP
- Revision to USP : 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
- Questions and Discussion
Who Will Benefit:
- Quality Control Personnel
- R&D Scientists
- Laboratory Supervisors and Managers
- Quality Assurance Personnel
- Chemists/Managers
- CMC or Regulatory Affairs Personnel
Speaker: Gregory Martin,
Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance
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To register/enquire, please contact:
www.compliance.world
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