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Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance
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.
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.
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
- QA/QCU managers and personnel
- Training department
- Documentation department
Greg 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 30 years’ experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for many years. In addition, he has volunteered for the USP for over 12 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, where he is a core member of the Residual Solvents Subcommittee. 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.
Compliance with compendial standards for residual solvents is required for all drug products provided in the United States, and similar requirements exist in all the major markets of the world. Since every product is unique, and since the requirements refer to over 50 different solvents, achieving compliance can be very challenging. Many, many firms have received incomplete or warning letters from the FDA as a result of failure to adequately address the reporting of residual solvents.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email firstname.lastname@example.org or call +1-650-620-3937.
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