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

Speaker

Instructor: Gregory Martin
Product ID: 705325

Location
  • Duration: 90 Min
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.
RECORDED TRAINING
Last Recorded Date: Jan-2018

 

$249.00
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)

$349.00
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)

 

 

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Read Frequently Asked Questions

Why Should You Attend:

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.

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. There will be ample opportunity for questions and discussion.

Learning Objectives:

Upon completion of this course the learner should 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

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Quality Control Personnel
  • R&D Scientists
  • Laboratory Supervisors and Managers
  • Quality Assurance Personnel
  • Chemists/Managers
  • CMC or Regulatory Affairs Personnel
Instructor Profile:
Gregory Martin

Gregory Martin
Founder and President, Complectors Consulting LLC

Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin applies over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations. His trainings (described on his webpage), whether live or webinars, are unusually interactive. 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 also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.

He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing 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 has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.

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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).

 

 

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