Nitrosamines, Elemental Impurities, Extractables and Leachables: A New Normal for the Pharma Industry

In this webinar, experts will discuss the current regulatory expectations for extractables and leachables (E&L), elemental impurities, and nitrosamines testing, as well as the latest advancements in analytical methods. Join to hear expert insights on how to expedite turnaround times during pharmaceutical product testing while preserving product quality and safety.

Register Free: https://globalmeet.webcasts.com/starthere.jsp?ei=1633456&tp_key=67e1438a81

Event Overview:

Extractables and leachables (E&L), elemental, and mutagenic impurities, such as nitrosamines, are important considerations in the safety assessment of small-molecule drugs. It is helpful to identify and eliminate or control any potential sources of contamination in drug products that could be hazardous to the patient. The recent recalls of nitrosamine-contaminated drugs underscore the need for robust analytical methods and risk-based approaches for E&L and nitrosamines testing. Additionally, drug product manufacturers must ensure that toxic elemental impurities are under a state of control in their products. To meet the demands of regulatory standards, proactive detection of genotoxic contaminants should be adopted at every stage of pharmaceutical development. Elemental impurities must be controlled in the final drug product to meet the demands of regulatory standards.

In this webinar, experts will discuss the current regulatory expectations for E&L, elemental impurities, and nitrosamines testing, as well as the latest advancements in analytical methods. The speakers will also provide practical recommendations for implementing risk-based approaches to E&L, elemental impurities, and nitrosamines testing in small-molecule drug development. In addition, experts will share insights on how to expedite turnaround times during pharmaceutical product testing while preserving product quality and safety.

Key Learning Objectives

• Understand nitrosamine precursors and impurities across drug development phases.
• Learn about the latest scientific advancements in analytical methods for E&L and nitrosamine testing.
• Gain practical recommendations for implementing risk-based approaches to E&L and nitrosamines testing in small-molecule drug development.

Who Should Attend

• C-Suite, R&D, formulation scientists, product development, CMC, and consultants

Speaker:

Prasad Panzade, PhD
Head of Analytical Sciences and Laboratory Operations
Catalent Morrisville

Dr Prasad Panzade is an executive with a broad vision and strategic entrepreneurial mindset with over 25 years of experience in the multidimensional chemical industries, including the pharmaceutical and biopharmaceutical industries. Dr Panzade holds a PhD in pharmaceutical sciences with specialization in the field of pharmaceutical analytical sciences and technology. He has been an active member of several professional organizations and a mentor who believes in creating more future leaders.

Dr Panzade is currently working with Catalent Pharma Solutions as Head of Analytical Sciences and Lab Operations. In the past, he has worked with Apotex Inc, Canada’s top generic pharmaceutical company, as a senior director of analytical R&D and quality control for global R&D. Prior to this position, he worked as a senior vice president for a multibillion-dollar conglomerate, Aditya Birla Group. He has held several positions in the API, specialty chemicals, polymer, and generic drug formulation industries. Dr Panzade is a speaker who provides active insights on the latest in the fields of analytical sciences. He has several peer-reviewed journal publications, articles published, and patents to his credits. Before moving into full-time positions in these industries, Dr Panzade has worked as a pharmaceutical college lecturer.

Register Free: https://globalmeet.webcasts.com/starthere.jsp?ei=1633456&tp_key=67e1438a81