In this free webinar, gain insights into the acquisition and qualification of reference standards for new drugs. Attendees will learn about the challenges in reference standard management and strategies to mitigate them. The featured speakers will discuss the critical role of reference standards in product quality and project timelines. They will share best practices for the storage and distribution of reference standards to collaborators and vendors. Attendees will also gain insights into the importance of a comprehensive reference standard management program in supporting key aspects of pharmaceutical development.
TORONTO, Dec. 13, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar focused on maintaining regulatory compliance with a high-quality reference standard program for pharmaceutical development. Reference standards are a cornerstone of the pharmaceutical industry, critical to assessing product quality, safety and potency during development. Throughout the drug development process, properly characterized reference standards are required to ensure quality control in critical areas such as the release of new product batches and stability evaluation. This webinar is designed for industry professionals looking to gain a practical understanding of reference standards, from their acquisition and qualification to their application in maintaining product quality and regulatory compliance.
A typical drug product may require a reference standard for not only the active pharmaceutical ingredient (API) but also for any number of degradation products, process impurities, metabolites or resolution components. For new drugs where compendial standards are unavailable, it is the responsibility of the sponsor to synthesize and characterize these materials. The featured speakers will delve into the analytical testing necessary for the qualification of these different standard types, with a focus on industry guidelines such as The Food and Drug Administration's (FDA) current good manufacturing practices (cGMP) and the International Council for Harmonisation (ICH).
This webinar will provide attendees with essential insights into the qualification and distribution of reference standards, and the importance of developing a formal program for reference standard management.
Join this webinar to gain the knowledge needed to maintain regulatory compliance by developing a high-quality reference standard program to support the entire pharmaceutical development process.
Join experts from MRIGlobal, John Cobb, Program Manager; and Audrey Ingram, PhD, Senior Chemist, for the live webinar on Tuesday, January 9, 2024, at 2pm EST (11am PST).
For more information, or to register for this event, visit Reference Standard Management for Pharmaceutical Development.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
SOURCE Xtalks
Share this article