Overview of USP and Ph. Eur. Allowable Adjustments for HPLC Monograph Methods

Register Free: https://www.chromatographyonline.com/lcgc_w/monograph_methods

Event Overview:

There is an on-going effort between the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.) (and others) to harmonize the allowable adjustments for high-performance liquid chromatography (HPLC) methods. However, at this time some differences do exist that can make it challenging for users of these validated Pharmacopeia monograph methods. This is especially true for companies that utilize both USP and Ph. Eur. monographs for their pharmaceutical drug substances and drug products. Understanding what adjustments are allowed and how they can help to avoid the need to revalidate methods, can result in improved laboratory efficiency and throughput. In this webinar, we will compare the allowable adjustments for USP and Ph. Eur. HPLC methods and include a couple of case studies.

Key Learning Objectives:

• Increased understanding of the relationship between the European Pharmacopoeia (Ph. Eur.) and US Pharmacopeia and the respective regulatory agencies in Europe (EDQM) and in the United States (FDA)
• Comparison of the allowable adjustments for USP and Ph. Eur. monograph HPLC methods and how they can impact laboratory efficiency and throughput

Speaker: Dr. Phil Koerner, Pharmaceutical Market Development Manager, Phenomenex

Time and Date: Thursday, March 18, 2021 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

On demand available until Mar. 18, 2022.

Sponsor: Phenomenex

Register Free: https://www.chromatographyonline.com/lcgc_w/monograph_methods