Residual Solvents: Understanding the Requirements and Practical Advice for Implementing USP <467>/ICH Q3C


Instructor: Gregory Martin
Product ID: 701916

  • Duration: 120 Min
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).
Last Recorded Date: Aug-2014


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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

Instructor Profile:

Gregory Martin,is President of Complectors Consulting ( which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. 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, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

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. He is also Past Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation. He can be contacted at [email protected].

Topic Background:

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.

Follow us :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund 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. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method