- 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
- 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
- Questions and Discussion
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.
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.
With a FREE membership you can get one Exclusive Video every 30 days!
With a free memebrship account, you can browse the entire library, buy credits & attend live webinars and read expert posts. Join and explore the coolest complaince platform ever. Feel free to upgrade anytime to view all Exclusive content and get additional benefits for your account.
Do I have to pay to join?
For FREE signups there is no payment required. No Credit Card needed. We also offer EDGE & PRO, paid memberships.
What are the different formats?
There are Live and Recorded, Expert led webinars. Durations vary from 30min to 6hrs. Standards & checklists are in pdf form
What if I am interested in more than one exclusive?
You can upgrade to EDGE memebrship at any time and enjoy unlimited Exclusive viewing. All our memebrships are annual plans.
How many videos can I watch?
As a FREE memebr you get 1 free exclusive video every 30days. You can buy additional videos.
Who are the Experts?
All Experts on our platform are handpicked or referred by other Experts based on years of experience & proven expertise in providing learning & consulting advice.
What if I have questions after watching a video?
We provide first of its kind, Expert on Call service, where you can directly schedule one on one call with the Expert of your choice & discuss.