Short Course Listings
 
Short Course

Course Information
Course Title: (CANCELED) Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
Categories: 1 - Pharmaceutical Sciences
2 - Quality/Regulatory/Compliance
3 - Gas Chromatography
4 - Validation
Instructor(s): Greg Martin Course Number: 138
Affiliation: Complectors Consulting
Course Date: 03/09/2017 - Thursday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
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. 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. There will ample opportunity for questions and discussion.

Target Audience
Chemists or managers responsible for testing or release of drug substances, excipients or drug products for which residual solvents must be controlled, and Quality Assurance and Regulatory Affairs/CMC personnel responsible for reviewing associated data or filings.

Course Outline
• 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

Course Instructor's Biography
Greg 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. He can be contacted at greg.martin@complectors.com.