Small Molecule Testing – Regulatory Expectations, Risk Assessment and Analytical Strategies

During this webinar, experts will share insights into current regulatory expectations on analytical test procedures for small molecules and provide recommendations for assessment, monitoring, and control of extractables and leachables (E&L) as well as genotoxic and elemental impurities, including Nitrosamines.

Register Free: https://www.pharmtech.com/pt_w/regulatory-expectations

Event Overview

Establishing a robust analytical method is an integral part of drug development's lifecycle in ensuring the safety and efficacy of drug substance and product. There are several challenges in analytical method development and validation for small molecules, especially in relation to establishing appropriate characterization and control strategies to assess the quality of pharmaceutical products. Therefore, selecting the best risk assessment and analytical testing strategy is key to reducing process turnaround times and enable efficient submission of regulatory filings.

During this webinar, experts will share insights into current regulatory expectations on analytical test procedures for small molecules and provide recommendations for assessment, monitoring, and control of extractables and leachables (E&L) as well as genotoxic and elemental impurities, including nitrosamines. Join this webinar to explore risk-based approaches to reduce the burden of analytical testing without compromising patient safety.

Key Learning Objectives

• Addressing analytical considerations in safety assessment and overcoming analysis challenges in drug substance and drug product.
• Learn how to manage regulatory, analytical, and other critical issues with efficient monitoring and control of elemental impurity, E&L, and nitrosamine.
• Discuss risk-based approaches to reduce the burden of analytical testing without compromising patient safety.

Who Should Attend

• R&D
• Formulation Development
• Analytical
• Clinical Development
• Manufacturing
• Procurement
• Consultants

Speakers

Vicki Schuler
General Manager
Catalent Morrisville

Vicki Schuler is the General Manager of Catalent’s facility in Morrisville, North Carolina. The Morrisville site is Catalent’s Center-of-Excellence for Analytical Services with support for an extensive range of small and large molecule analytical projects. Prior to this, Vicki was the Vice President of Quality for the oral delivery platform, across Catalent’s US sites. She has been with Catalent for 7 years and has 20 years of industry experience and progressive Quality leadership roles at Bristol-Myers Squibb, Johnson Matthey Pharma Services and Endo (Qualitest) Pharmaceuticals. Vicki has a degree in chemistry from the State University of New York as well as a master's degree in chemistry from the University of South Florida.

David Elder has nearly 40 years of service within the pharmaceutical industry at Sterling, Syntext and GlaxoSmithKline. He is now an independent GMC consultant. He is a visiting professor at King’s College, London and is a member of the British Pharmacopoeia. He is a member of the Joint Pharmaceutical Analysis Group (JPAG) and the Analytical Division Council of the Royal Society of Chemistry.

Register Free: https://www.pharmtech.com/pt_w/regulatory-expectations