Challenges with Verification of Compendial Chromatographic Methods

Pace Analytical

Webcast

*Live: Thursday, May 27, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST* Compendial verification is a regulatory requirement. Often overlooked are the technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory. Experts will share experiences gained over years of evaluating hundreds of methods to help you avoid similar obstacles and delays in your laboratory. *On Demand Until May 27, 2022*

Register free: https://www.pharmtech.com/pt_w/compendial

Event Overview:

Compendial verification is a regulatory requirement in various phases of drug development. The technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory is often overlooked.

This webcast will discuss a series of case studies that illustrate the importance of performing robust compendial verification in your laboratory. Experts will describe the technical challenges encountered, while evaluating a variety of active pharmaceutical ingredients and excipients and explaining how those challenges were resolved.

Challenges include:

  • Sample preparation methodology that led to ruptured vials
  • High-purity reference standards unavailable from commercial sources
  • Reference standards of uncertain purity or potentially contaminated
  • Standard preparation methods that may be hazardous or present safety concern

Key Learning Objectives:

  • Understand the value added by performing compendial verification to demonstrate suitability under the actual conditions of use in your laboratory.
  • Assess why compendial verification data is needed to ensure potential technical and safety issues are identified.
  • Identify analytical details and techniques that may not be included in the compendial procedure but are essential for a robust method.

Time and Date: Thursday, May 27, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

Register free: https://www.pharmtech.com/pt_w/compendial