Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

Duration: 90 Minutes
flat 50% off on this webinar
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).
Instructor: Gregory Martin
Product ID: 507766
Objectives of the Presentation
Upon completion of this course the participants will 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 <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
Why Should you Attend
This webinar will focus on recent changes to USP <467> which can increase flexibility and reduce workload for testing of residual solvents in raw materials and finished products. We address 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.

Areas Covered
  • 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 not yet addressed
  • 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
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.
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the 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 the 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 on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, 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. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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