ComplianceOnline

Register

Toll Free: +1-888-717-2436


customer care
Fax: +1-650-963-2556
Email: editor@complianceonline.com
Read Frequently Asked Questions

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

Buy Now Section

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).

Speaker
Instructor: Gregory Martin
Product ID: 701916

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:

Areas Covered in the Webinar:

Who Will Benefit:

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

Instructor Profile:

Gregory Martin,is President of Complectors Consulting (www.complectors.com) 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 greg.martin@complectors.com.

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.

Bookmark and Share
Refund Policy
"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 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 editor@complianceonline.com or call +1-650-620-3937.

FDA's GMP Expectations for Phase - 80039SEM
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices - 80066SEM

This training hasn't been reviewed yet.

Review this training

Training Options Training Duration = 120 Min
$599.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days