ComplianceOnline

4hr Virtual Seminar: Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance

Instructor: Gregory Martin
Product ID: 702042
  • Duration: 4 hrs

Training CD

$899.00
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

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 4hr 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).

Why Should You Attend:

This course 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).

We will discuss controlling residual solvents in incoming materials as well as those introduced during manufacture. We 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, and after the presentation there will be an opportunity for questions and discussion.

Agenda: (All time in EDT)

  • 11:00 – 11:40      Introduction:  Regulatory Landscape for Residual Solvents
  • 11:40 – 12:25      Controlling Residual Solvents in Incoming Materials or Those Introduced During Manufacturing
  • 12:25 – 12:00      Analytical Procedures for Residual Solvents:  Compendial Procedures, Alternative Procedures and Reference Standards
  • 12:00 – 1:15        Break
  • 1:15 – 2:00           Strategies for Compliance:  Testing and Avoiding Testing
  • 2:00 – 2:20           Reporting Residual Solvents:  Assuring You Address Regulators' Concerns
  • 2:20 – 2:45           Frequently Asked Questions, including Feedback from FDA
  • 2:45 – 2:55           Summary and Conclusions
  • 2:55 – 3:15           Questions and Discussion

Learning Objectives:

Upon completion of this course the participant should be able to:

  • Understand the requirements for residual solvents addressed in ICH, USP, EP and JP.
  • Identify the classes of solvents and address sources of solvents.
  • Effectively utilize options for describing residual solvents.
  • Select appropriate analytical procedures.
  • Utilize strategies to minimize the testing and resources required to meet the requirements.
  • Report levels of residual solvents appropriately.

Areas Covered in the Seminar:

  • Introduction to Regulatory Landscape for Residual Solvents.
  • Controlling Residual Solvents in Incoming Materials or Those Introduced During Manufacturing.
  • Analytical Procedures for Residual Solvents:  Compendial Procedures, Alternative Procedures and Reference Standards.
  • Strategies for Compliance:  Testing and Avoiding Testing.
  • Reporting Residual Solvents:  Assuring You Address Regulators' Concerns.
  • Frequently Asked Questions, including Feedback from FDA.

Who Will Benefit:

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.

Instructor Profile:

Greg 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 30 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for many years.  In addition, he has volunteered for the USP for over 12 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, where he is a core member of the Residual Solvents Subcommittee.  He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group.  He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance. 

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